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CompletedNCT04137289Updated Mar 25, 2025Results posted

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

A Phase 1 interventional study of BI 905711 in Gastrointestinal Neoplasms, Cholangiocarcinoma and Pancreatic Neoplasms, sponsored by Boehringer Ingelheim. Completed at 18 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Phase 1a - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3).

Phase 1a - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD.

Phase 1b - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

02

Conditions studied

  • Gastrointestinal Neoplasms
  • Cholangiocarcinoma
  • Pancreatic Neoplasms
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 110 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • a. Phase Ia (dose escalation only)

Histologically or cytologically confirmed, advanced unresectable or metastatic gastrointestinal cancers of following histologies:

  • Colorectal adenocarcinoma
  • Gastric adenocarcinoma
  • Esophageal adenocarcinoma
  • Pancreatic adenocarcinoma
  • Cholangiocarcinoma and gallbladder carcinoma
  • Small intestine adenocarcinoma b. Phase Ib (expansion phase)

  • Histologically or cytologically confirmed, advanced unresectable or metastatic colorectal adenocarcinoma.

    • Patient who has failed all available conventional therapies known to confer clinical benefit for their disease based on local approved standards. For patients with colorectal cancer, prior treatment with regorafenib or TAS-102 is optional.
    • Phase Ia (dose escalation) only: Patient with either measurable or non-measurable/non-evaluable disease.
    • Phase Ia (expanded cohort) and Phase Ib (expansion phase) only: At least one target lesion that can be accurately measured per RECIST v.1.1
    • Availability and willingness to provide an archived tumor tissue specimen and undergo tumor biopsy before treatment. Pre-treatment fresh tumor biopsy collections for biomarker analyses are considered optional in phase Ia and mandatory in phase Ib. Only nonsignificant risk procedures per the investigator's judgment will be used to obtain any biopsies specified in this study. In case a fresh tumor biopsy cannot be obtained due to before mentioned reasons an archived tumor tissue specimen obtained within ≤6 months of screening must be submitted. In case the patient undergoes baseline tumor biopsy, an archived tumor tissue specimen must be submitted regardless of the date of collection.
    • Adequate hepatic, renal and bone marrow functions as defined by all of the below:
  • Total bilirubin ≤ 1.5 x institutional Upper Level of Normal (ULN) (≤ 3 x institutional ULN for patient with Gilbert's syndrome)
  • ALT and AST ≤2.5 x institutional ULN (≤5 x institutional ULN for patients with known liver metastases)
  • Serum creatinine ≤1.5x institutional ULN. If creatinine is > 1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥ 50 ml/min (>0.05 L/min) (measured or calculated by CKD-EPI formula or Japanese version of CKD-EPI formula for Japanese patients).
  • ANC ≥ 1.0x 10\^9/L (≥ 1.0 x 10\^3/μL, ≥ 1,000/mm3)
  • Platelets ≥ 100x10\^9/ L (≥ 100 x 10\^3/μL, ≥ 100 x 10\^3/mm3)
  • Hemoglobin (Hb) ≥8.5 g/dl, ≥ 85 g/L, or ≥ 5.3 mmol/L (without transfusion within previous week)

  • Serum lipase ≤ 1.5 institutional ULN

    • Recovery from any adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 of previous anti-cancer therapies to baseline or CTCAE grade 1, except for alopecia CTCAE grade 2, sensory peripheral neuropathy CTCAE grade ≤ 2 or considered not clinically significant.
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    • Life expectancy ≥ 3 months in the opinion of the investigator
    • Of legal adult age (according to local legislation) at screening
    • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
    • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion criteria

Exclusion Criteria:

  • Previous systemic anti-cancer therapy within the specified timeframe from the last dose intake to the first dose of trial treatment as shown below:

    • Any non-investigational drug, including anti-angiogenic antibodies (bevacizumab or ramucirumab) and anti-EGFR antibodies (cetuximab or panitumumab), within 14 days.
    • Any investigational drug or other antibodies including immune checkpoint inhibitors, within 28 days.
  • Radiation therapy within 4 weeks prior to start of treatment. However, palliative radiotherapy for symptomatic metastasis is allowed if completed within 2 weeks prior to start of treatment but must be discussed with the sponsor.
  • Any serious concomitant disease or medical condition affecting compliance with Trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal (GI) tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator, would make the patient inappropriate for entry into the trial. Any history of stroke or myocardial infarction within 6 months prior to screening.

  • Known pathological condition of GI tract, liver and pancreas, excluding the disease under study, that may interfere with assessment of drug safety or may increase the risk of toxicity:

    • inflammatory bowel disease
    • chronic pancreatitis
    • other serious GI pathological conditions by judgment of the investigator e.g. autoimmune disease with GI involvement, unexplained active diarrhea CTCAE grade ≥2 according to CTCAE v5.0.
  • Known history of human immunodeficiency virus infection.

  • Any of the following laboratory evidence of hepatitis virus infection. Test results obtained in routine diagnostics are acceptable if done within 14 days before the informed consent date:

    • Positive results of hepatitis B surface (HBs) antigen
    • Presence of HBc antibody together with HBV-DNA
    • Presence of hepatitis C RNA
  • Active concomitant malignancies, other than the one treated in this trial.
  • Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to comply with the protocol requirements or not expected to complete the trial as scheduled.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial; female patients who do not agree to the interruption of breast feeding from the start of study treatment to within 30 days after the last study treatment.
  • Presence of uncontrolled or symptomatic brain or subdural metastases. Inclusion of patients with brain metastases who have completed local therapy and are considered stable by the investigator, or with newly identified asymptomatic brain metastases at screening will be allowed. Use of corticosteroids is allowed if the dose was stable for at least 1 week before the baseline MRI.
  • Patients who are under judicial protection and patients who are legally institutionalized
  • Major surgery (major according to the investigator's assessment) performed within 3 weeks prior to treatment start or planned within 3 months after screening, e.g. hip replacement.

  • Any of the following cardiac criteria:

    • Resting corrected QT interval (QTc) >470 msec
    • Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block
    • Patients with an ejection fraction (EF) \<50% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram, multi-gated acquisition scan). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.
  • Known hypersensitivity to the trial medication and/or its components i.e. polysorbate 20, sodium citrate, lysine hydrochloride, sucrose, citric acid.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    BI 905711 0.02 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.

    Drug: BI 905711

  • Experimental
    BI 905711 0.06 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.

    Drug: BI 905711

  • Experimental
    BI 905711 0.2 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.

    Drug: BI 905711

  • Experimental
    BI 905711 0.6 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.

    Drug: BI 905711

  • Experimental
    BI 905711 0.6 mg/kg, QW

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).

    Drug: BI 905711

  • Experimental
    BI 905711 1.2 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.

    Drug: BI 905711

  • Experimental
    BI 905711 2.4 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.

    Drug: BI 905711

  • Experimental
    BI 905711 3.6 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.

    Drug: BI 905711

  • Experimental
    BI 905711 4.8 mg/kg, Q2W

    Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.

    Drug: BI 905711

Interventions

  • DrugBI 905711

    BI 905711

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of BI 905711 in Phase 1a

    Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true drug limiting dose (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD is above 0.5 or at least 15 patients have been treated in phase 1a, of which at least 6 were at the MTD.

    Time frame: From cycle 1 Day 1 until the second administration of study treatment (two 14-day treatment cycles).

  2. Number of Patients With Dose-limiting Toxicity (DLT) During the MTD Evaluation Period in Phase 1a

    Number of patients with dose-limiting toxicity (DLT) during the MTD evaluation period is reported.

    Time frame: From cycle 1 Day 1 until the day before cycle 3 Day 1 (two 14-day treatment cycles).

  3. Confirmed Objective Response (OR) for Phase 1a and Phase 1b Combined

    Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with measurable disease is reported. This was defined as the best overall response of complete response (CR) or partial response (PR), where best overall response was the best response recorded from the start of the study treatment until the earliest of disease progression, death, or last evaluable tumor assessment and before start of subsequent anticancer therapy.

    Time frame: From the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, up to 48 weeks.

  4. Progression-free Survival (PFS)

    This was evaluated per RECIST 1.1 criteria for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response at each time point was evaluated by target lesion, non-target lesions and new lesions together, according to RECIST 1.1. Objective response (OR) was defined as best overall response of confirmed CR or confirmed PR according to RECIST 1.1.

    Time frame: From the first administration of trial medication until tumor progression or death, whichever occurred first, up to 48 weeks.

Secondary outcomes

  1. Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1a

    Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1a is reported.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.

  2. Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1a

    Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1a is reported.

    Time frame: Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.

  3. Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the First Cycle in Phase 1a

    Area under the concentration-time curve (AUC0-336) of BI 905711 during the first cycle in phase 1a is reported.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1 .

  4. Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the Third Cycle in Phase 1a

    Area under the concentration-time curve (AUC0-336) of BI 905711 during the third cycle in phase 1a is reported.

    Time frame: Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.

  5. Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1b

    Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1b is reported.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.

  6. Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1b

    Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1b is reported.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.

  7. Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the First Cycle in Phase 1b

    Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the first cycle in phase 1b is reported. 11. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.

  8. Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the Third Cycle in Phase 1b

    Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the third cycle in phase 1b is reported. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

    Time frame: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.

  9. Number of Patients With Treatment-emergent Adverse Events (AEs)

    The number of patients with treatment-emergent adverse events (AEs) is reported, namely, all adverse events occurring between start of treatment and end of the residual effect period (REP). Adverse events that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

    Time frame: From start of treatment until the last dose of trial medication plus the residual effect period (REP), up to 358 days.

  10. Maximum Percentage Change From Baseline in the Sum of Target Lesion Diameters

    Radiological (CT scan) tumor shrinkage, defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of the longest diameters of the same set of target lesions according to RECIST 1.1 is reported. Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase.

    Time frame: At baseline and every 8 weeks (± 7 days) until progression or start of further treatment for disease, up to 48 weeks.

  11. Duration of Overall Response

    The duration of overall response was measured from the time measurement criteria were first met for complete response (CR) / partial response (PR) (whichever was first recorded) until the first date that recurrent or progression disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded in the study) according to RECIST 1.1.

    Time frame: From the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented, up to 48 weeks.

  12. Disease Control

    Disease control was defined as complete response (PR), partial response (PR), or stable disease according to RECIST 1.1 from the start of treatment until the earliest of progression disease (PD), death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy. This endpoint analyzed the number of patients meeting this criterion.

    Time frame: From the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy, up to 48 weeks.

07

Results

Posted Mar 25, 2025
Limitations and caveats
Based on available preliminary data from Phase 1 clinical studies (1412-0001 and 1412-0003), the decision was made to terminate the BI 905711 (TRAILR2/CDH17) development program. This decision was not related to any safety concerns or unfavorable benefit/risk balance, but to the lack of predictive biomarkers and the limited efficacy, particularly in the context of the evolving treatment landscape for advanced colorectal cancer (CRC) and other gastrointestinal (GI) cancers.

Participant flow

The objectives of this phase 1a/b, open-label, multicenter, dose escalation and dose expansion trial were to explore safety and establish maximum tolerated dose (MTD) of BI 905711 in patients with gastrointestinal cancers, as well as to explore pharmacokinetics, pharmacodynamics, and efficacy. Recruitment for the trial was discontinued during Phase 1b and no PDAC (pancreatic ductal adenocarcinoma) patients were enrolled as originally planned.

Participant flow — Overall Study
MilestoneBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Started1172316232487
Treated in phase 1a117808887
Treated in phase 1b0001516151600
Completed000000000
Not completed1172316232487
Withdrew: Death000000100
Withdrew: Clinical disease progression000442510
Withdrew: Lost to follow-up000100000
Withdrew: Adverse event001001000
Withdrew: Lack of clinical benefit000000001
Withdrew: Objective disease progression1161812201876

Outcome measures

PrimaryMaximum Tolerated Dose (MTD) of BI 905711 in Phase 1a

Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true drug limiting dose (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD is above 0.5 or at least 15 patients have been treated in phase 1a, of which at least 6 were at the MTD.

Time frame:
From cycle 1 Day 1 until the second administration of study treatment (two 14-day treatment cycles).
Reported as:
Number · milligram / kilogram (mg/kg)
Maximum Tolerated Dose (MTD) of BI 905711 in Phase 1a
milligram / kilogram (mg/kg)BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W
Maximum Tolerated Dose (MTD) of BI 905711 in Phase 1aNA
PrimaryNumber of Patients With Dose-limiting Toxicity (DLT) During the MTD Evaluation Period in Phase 1a

Number of patients with dose-limiting toxicity (DLT) during the MTD evaluation period is reported.

Time frame:
From cycle 1 Day 1 until the day before cycle 3 Day 1 (two 14-day treatment cycles).
Reported as:
Count of participants · Participants
Number of Patients With Dose-limiting Toxicity (DLT) During the MTD Evaluation Period in Phase 1a
ParticipantsBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Number of Patients With Dose-limiting Toxicity (DLT) During the MTD Evaluation Period in Phase 1a00000000
PrimaryConfirmed Objective Response (OR) for Phase 1a and Phase 1b Combined

Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with measurable disease is reported. This was defined as the best overall response of complete response (CR) or partial response (PR), where best overall response was the best response recorded from the start of the study treatment until the earliest of disease progression, death, or last evaluable tumor assessment and before start of subsequent anticancer therapy.

Time frame:
From the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, up to 48 weeks.
Reported as:
Number · Participants
Confirmed Objective Response (OR) for Phase 1a and Phase 1b Combined
ParticipantsBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Confirmed Objective Response (OR) for Phase 1a and Phase 1b Combined0 (0 to 97.5)0 (0 to 97.5)0 (0 to 45.9)0 (0 to 15.4)0 (0 to 21.8)0 (0 to 15.4)0 (0 to 15.4)0 (0 to 36.9)0 (0 to 41.0)
PrimaryProgression-free Survival (PFS)

This was evaluated per RECIST 1.1 criteria for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response at each time point was evaluated by target lesion, non-target lesions and new lesions together, according to RECIST 1.1. Objective response (OR) was defined as best overall response of confirmed CR or confirmed PR according to RECIST 1.1.

Time frame:
From the first administration of trial medication until tumor progression or death, whichever occurred first, up to 48 weeks.
Reported as:
Median · weeks
Progression-free Survival (PFS)
weeksBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Progression-free Survival (PFS)6.29 (NA to NA)18.14 (NA to NA)5.71 (1.86 to 6.14)7.36 (5.29 to 12.00)7.43 (7.14 to 8.00)6.14 (4.57 to 8.00)7.14 (5.43 to 12.71)11.43 (4.86 to 20.14)7.43 (4.29 to 8.14)
SecondaryMaximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1a

Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1a is reported.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Reported as:
Geometric mean · nanograms/milliliter (ng/ml)
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1a
nanograms/milliliter (ng/ml)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1a306 ± NA492 ± NA2110 ± 16.16690 ± 18.411900 ± 29.526200 ± 24.340700 ± 22.561000 ± 26.9
SecondaryMaximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1a

Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1a is reported.

Time frame:
Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Reported as:
Geometric mean · nanograms/milliliter (ng/ml)
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1a
nanograms/milliliter (ng/ml)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1a336 ± NA497 ± NA2580 ± 17.57030 ± 20.910300 ± 44.831900 ± 26.447700 ± 23.950300 ± 32.1
SecondaryArea Under the Concentration-time Curve (AUC0-336) of BI 905711 During the First Cycle in Phase 1a

Area under the concentration-time curve (AUC0-336) of BI 905711 during the first cycle in phase 1a is reported.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1 .
Reported as:
Geometric mean · hour*nanogram/milliliter (h*ng/mL)
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the First Cycle in Phase 1a
hour*nanogram/milliliter (h*ng/mL)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the First Cycle in Phase 1a—20000 ± NA97500 ± 39.5391000 ± 50.1872000 ± 39.81770000 ± 52.03330000 ± 22.34590000 ± 29.8
SecondaryArea Under the Concentration-time Curve (AUC0-336) of BI 905711 During the Third Cycle in Phase 1a

Area under the concentration-time curve (AUC0-336) of BI 905711 during the third cycle in phase 1a is reported.

Time frame:
Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Reported as:
Geometric mean · hour*nanogram/milliliter (h*ng/mL)
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the Third Cycle in Phase 1a
hour*nanogram/milliliter (h*ng/mL)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the Third Cycle in Phase 1a—24500 ± NA104000 ± 26.8358000 ± 37.2717000 ± 21.31990000 ± 76.33390000 ± 41.23990000 ± 63.3
SecondaryMaximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1b

Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1b is reported.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.
Reported as:
Geometric mean · nanograms/milliliter (ng/ml)
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1b
nanograms/milliliter (ng/ml)BI 905711 0.6 mg/kg, QWBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2W
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1b5740 ± 31.06150 ± 31.010700 ± 36.723100 ± 26.6
SecondaryMaximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1b

Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1b is reported.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.
Reported as:
Geometric mean · nanograms/milliliter (ng/ml)
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1b
nanograms/milliliter (ng/ml)BI 905711 0.6 mg/kg, QWBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2W
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1b5630 ± 28.06310 ± 47.813600 ± 39.523100 ± 20.9
SecondaryArea Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the First Cycle in Phase 1b

Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the first cycle in phase 1b is reported. 11. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.
Reported as:
Geometric mean · hour*nanogram/milliliter (h*ng/mL)
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the First Cycle in Phase 1b
hour*nanogram/milliliter (h*ng/mL)BI 905711 0.6 mg/kg, QWBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2W
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the First Cycle in Phase 1b323000 ± 48.0302000 ± 40.6573000 ± 55.31460000 ± 50.0
SecondaryArea Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the Third Cycle in Phase 1b

Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the third cycle in phase 1b is reported. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

Time frame:
Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.
Reported as:
Geometric mean · hour*nanogram/milliliter (h*ng/mL)
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the Third Cycle in Phase 1b
hour*nanogram/milliliter (h*ng/mL)BI 905711 0.6 mg/kg, QWBI 905711 0.6 mg/kg, Q2WBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2W
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the Third Cycle in Phase 1b354000 ± 42.9339000 ± 48.1571000 ± 78.91460000 ± 55.9
SecondaryNumber of Patients With Treatment-emergent Adverse Events (AEs)

The number of patients with treatment-emergent adverse events (AEs) is reported, namely, all adverse events occurring between start of treatment and end of the residual effect period (REP). Adverse events that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

Time frame:
From start of treatment until the last dose of trial medication plus the residual effect period (REP), up to 358 days.
Reported as:
Count of participants · Participants
Number of Patients With Treatment-emergent Adverse Events (AEs)
ParticipantsBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Number of Patients With Treatment-emergent Adverse Events (AEs)1152216232087
SecondaryMaximum Percentage Change From Baseline in the Sum of Target Lesion Diameters

Radiological (CT scan) tumor shrinkage, defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of the longest diameters of the same set of target lesions according to RECIST 1.1 is reported. Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase.

Time frame:
At baseline and every 8 weeks (± 7 days) until progression or start of further treatment for disease, up to 48 weeks.
Reported as:
Mean · Percentage change in tumor diameter
Maximum Percentage Change From Baseline in the Sum of Target Lesion Diameters
Percentage change in tumor diameterBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Maximum Percentage Change From Baseline in the Sum of Target Lesion Diameters13.6 ± NA-2.4 ± NA28.8 ± 13.8520.8 ± 28.8626.6 ± 26.4334.3 ± 24.7618.2 ± 25.9019.3 ± 20.9326.8 ± 23.02
SecondaryDuration of Overall Response

The duration of overall response was measured from the time measurement criteria were first met for complete response (CR) / partial response (PR) (whichever was first recorded) until the first date that recurrent or progression disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded in the study) according to RECIST 1.1.

Time frame:
From the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented, up to 48 weeks.
Reported as:
Mean · Days
Duration of Overall Response
DaysBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Duration of Overall Response—127.0 ± NA—170.3 ± 84.5196.5 ± 119.587.0 ± 58.0190.7 ± 78.790.5 ± 45.5260.0 ± NA
SecondaryDisease Control

Disease control was defined as complete response (PR), partial response (PR), or stable disease according to RECIST 1.1 from the start of treatment until the earliest of progression disease (PD), death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy. This endpoint analyzed the number of patients meeting this criterion.

Time frame:
From the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy, up to 48 weeks.
Reported as:
Count of participants · Participants
Disease Control
ParticipantsBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Disease Control010722641

Adverse events

Collected over Up to 358 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BI 905711 0.02 mg/kg, Q2W1/1 (100%)0/1 (0%)1/1 (100%)
BI 905711 0.06 mg/kg, Q2W1/1 (100%)1/1 (100%)1/1 (100%)
BI 905711 0.2 mg/kg, Q2W5/7 (71.4%)2/7 (28.6%)5/7 (71.4%)
BI 905711 0.6 mg/kg, Q2W15/23 (65.2%)14/23 (60.9%)22/23 (95.7%)
BI 905711 0.6 mg/kg, QW6/16 (37.5%)4/16 (25%)16/16 (100%)
BI 905711 1.2 mg/kg, Q2W15/23 (65.2%)7/23 (30.4%)23/23 (100%)
BI 905711 2.4 mg/kg, Q2W11/24 (45.8%)10/24 (41.7%)19/24 (79.2%)
BI 905711 3.6 mg/kg, Q2W7/8 (87.5%)2/8 (25%)7/8 (87.5%)
BI 905711 4.8 mg/kg, Q2W4/7 (57.1%)1/7 (14.3%)7/7 (100%)
Most frequent serious events
Showing 10 of 47
Most frequent serious events
EventBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Adrenal insufficiencyEndocrine disorders0/11/10/70/230/160/230/240/80/7
HyponatraemiaMetabolism and nutrition disorders0/11/10/70/230/160/230/240/80/7
Liver abscessInfections and infestations0/10/11/70/230/160/230/240/80/7
Blood bilirubin increasedInvestigations0/10/11/70/230/160/230/240/80/7
Ischaemic strokeNervous system disorders0/10/11/70/230/160/230/240/80/7
DyspnoeaRespiratory, thoracic and mediastinal disorders0/10/10/71/230/160/231/240/81/7
EmbolismVascular disorders0/10/10/70/230/160/230/240/81/7
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/10/10/72/230/163/231/241/80/7
Pleural effusionRespiratory, thoracic and mediastinal disorders0/10/10/70/230/160/230/241/80/7
Abdominal painGastrointestinal disorders0/10/10/72/230/161/230/240/80/7
Most frequent other events
Showing 10 of 101
Most frequent other events
EventBI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2W
Abdominal discomfortGastrointestinal disorders1/10/10/70/230/160/230/240/80/7
NauseaGastrointestinal disorders0/11/11/73/235/1611/234/242/82/7
PyrexiaGeneral disorders0/11/11/74/230/165/233/240/82/7
CholangitisHepatobiliary disorders1/10/10/70/230/160/230/240/80/7
EczemaSkin and subcutaneous tissue disorders1/10/11/70/230/160/230/240/80/7
AnaemiaBlood and lymphatic system disorders0/10/11/76/233/163/235/240/83/7
CoughRespiratory, thoracic and mediastinal disorders0/10/11/72/235/162/232/240/81/7
Abdominal painGastrointestinal disorders0/10/12/76/232/166/235/241/80/7
Abdominal pain upperGastrointestinal disorders0/10/12/70/231/161/232/240/80/7
Aspartate aminotransferase increasedInvestigations0/10/12/74/230/164/234/241/82/7

Baseline characteristics

Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. This TS was used for both safety and efficacy analyses.

Age, Continuous
Age, Continuous(Years)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2WTotal
Mean59.071.064.3 ± 6.756.0 ± 10.157.3 ± 10.557.7 ± 11.563.0 ± 10.964.9 ± 7.062.4 ± 6.859.8 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2WTotal
Female0019716102247
Male1161497146563
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2WTotal
Hispanic or Latino0001133008
Not Hispanic or Latino117191418198794
Unknown or Not Reported0003122008
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BI 905711 0.02 mg/kg, Q2WBI 905711 0.06 mg/kg, Q2WBI 905711 0.2 mg/kg, Q2WBI 905711 0.6 mg/kg, Q2WBI 905711 0.6 mg/kg, QWBI 905711 1.2 mg/kg, Q2WBI 905711 2.4 mg/kg, Q2WBI 905711 3.6 mg/kg, Q2WBI 905711 4.8 mg/kg, Q2WTotal
American Indian or Alaska Native0000000000
Asian11121242216
Native Hawaiian or Other Pacific Islander0000100001
Black or African American0011000114
White005171318185480
More than one race0000000000
Unknown or Not Reported0003132009
08

Study locations

18 sites
  • Yale Cancer Center
    New Haven, Connecticut 06511, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10022, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • START South Texas Accelerated Research Therapeutics, LLC
    San Antonio, Texas 78229, United States
  • Brussels - UNIV Saint-Luc
    Bruxelles, 1200, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • Beijing Cancer Hospital
    Beijing, 100142, China
  • The Sixth Affiliated Hospital of Sun Yat-sen University
    Guangzhou, 510655, China
  • HOP Jean Minjoz
    Besançon, 25030, France
  • CTR Leon Berard
    Lyon, 69373, France
  • HOP la Milétrie
    Poitiers, 86021, France
  • CTR Eugène Marquis
    Rennes, 35042, France
  • Universitätsklinikum Mannheim GmbH
    Mannheim, 68167, Germany
  • National Cancer Center Hospital East
    Chiba, Kashiwa, 277-8577, Japan
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Ramón y Cajal
    Madrid, 28034, Spain
  • Hospital Clínico de Valencia
    Valencia, 46010, Spain
09

References and documents

Publications

  • Garcia-Martinez JM, Wang S, Weishaeupl C, Wernitznig A, Chetta P, Pinto C, Ho J, Dutcher D, Gorman PN, Kroe-Barrett R, Rinnenthal J, Giragossian C, Impagnatiello MA, Tirapu I, Hilberg F, Kraut N, Pearson M, Kuenkele KP. Selective Tumor Cell Apoptosis and Tumor Regression in CDH17-Positive Colorectal Cancer Models using BI 905711, a Novel Liver-Sparing TRAILR2 Agonist. Mol Cancer Ther. 2021 Jan;20(1):96-108. doi: 10.1158/1535-7163.MCT-20-0253. Epub 2020 Oct 9. PubMed 33037135 ↗

Related links

Study documents

  • Study protocol · Apr 17, 2023
  • Statistical analysis plan · Dec 7, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04137289
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 24, 2019
Start date
Mar 11, 2020
Primary completion
Jul 26, 2023
Completion
Nov 27, 2023
Results posted
Mar 25, 2025
Last update
Mar 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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