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TerminatedNCT03576131Updated Aug 1, 2023Results posted

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors

A Phase 1/2 interventional study of GEN1029 (HexaBody®-DR5/DR5) in Colorectal Cancer, Non-small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by Genmab. Terminated at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Genmab · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

Read the detailed description

The trial is an open-label, multi-center first-in-human trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

02

Conditions studied

  • Colorectal Cancer
  • Non-small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Renal Cell Carcinoma
  • Gastric Cancer
  • Pancreatic Cancer
  • Urothelial Cancer
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 48 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Genmab is the lead sponsor of 67 studies on the registry; 14 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 12 (52%) 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

  • Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial.
  • Patient must be ≥ 18 years of age
  • Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
  • Have an acceptable hematological status
  • Have an acceptable renal function
  • Have an acceptable liver function
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Body weight ≥ 40kg
  • Patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of GEN1029

Exclusion criteria

Exclusion Criteria (main):

  • Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first GEN1029 administration
  • Have clinically significant cardiac disease
  • Have uncontrolled hypertension as defined in the protocol
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
  • History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of Investigational Medicinal Product (IMP)
  • Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first GEN1029 administration
  • History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial
  • Radiotherapy within 14 days prior to first GEN1029 administration
  • Any prior therapy with a compound targeting DR4 or DR5
  • History of chronic liver disease or evidence of hepatic cirrhosis
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    GEN1029 (HexaBody®-DR5/DR5)

    Biological: GEN1029 (HexaBody®-DR5/DR5)

Interventions

  • BiologicalGEN1029 (HexaBody®-DR5/DR5)

    GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).

    Time frame: From Day 1 to 28 days after the first dose of study drug

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.

    Time frame: Day 1 through Day 565 (corresponding to maximum observed duration)

  3. Number of Participants With >= Grade 3 Laboratory Results

    Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.

    Time frame: Day 1 through Day 565 (corresponding to maximum observed duration)

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

    The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  2. Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

    The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  3. Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

    The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  4. Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

    The CL of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  5. Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05

    The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  6. Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

    The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  7. Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

    The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  8. Plasma Concentration of Hx-DR5-01 and Hx-DR5-05

    The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.

    Time frame: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

  9. Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

    From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.

    Time frame: From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)

  10. Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

    Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.

    Time frame: From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)

  11. Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.

    Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

  12. Progression-Free Survival (PFS) According to RECIST 1.1

    The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.

    Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

  13. Overall Survival (OS) According to RECIST 1.1

    Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.

    Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

  14. Duration of Response (DoR) According to RECIST 1.1

    The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.

    Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

  15. Time to Response (TTR) According to RECIST 1.1

    TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.

    Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

07

Results

Posted Dec 12, 2022
Limitations and caveats
Results of the biweekly dosing regimens are based on the Clinical Study Report.

Participant flow

Participant flow — Overall Study
MilestoneBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)
Started1074117711
Completed12000000
Not completed954117711
Withdrew: Investigator decision00010100
Withdrew: Withdrawal by subject11012310
Withdrew: Death33154101
Withdrew: New anti-cancer treatment51230000
Withdrew: Unspecified reason00111100
Withdrew: Subject non-compliance00000100

Outcome measures

PrimaryNumber of Participants With Dose Limiting Toxicities (DLTs)

DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).

Time frame:
From Day 1 to 28 days after the first dose of study drug
Reported as:
Count of participants · Participants
Number of Participants With Dose Limiting Toxicities (DLTs)
ParticipantsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of Participants With Dose Limiting Toxicities (DLTs)010332
PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.

Time frame:
Day 1 through Day 565 (corresponding to maximum observed duration)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
ParticipantsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Any TEAE8741177
Any TESAE332964
PrimaryNumber of Participants With >= Grade 3 Laboratory Results

Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.

Time frame:
Day 1 through Day 565 (corresponding to maximum observed duration)
Reported as:
Count of participants · Participants
Number of Participants With >= Grade 3 Laboratory Results
ParticipantsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Activated partial thromboplastin time prolonged010000
Alanine aminotransferase increased112312
Alkaline phosphatase increased001010
Amylase increased011000
Asparate aminotransferase increased120002
Bilirubin increased000100
Calcium decreased010000
Creatinine increased100000
Gamma-glutamyl transferase increased221231
Glucose increased211300
Hemoglobin decreased010000
Lipase increased103100
Lymphocytes decreased231220
Magnesium increased000001
Prothrombin international normalized ratio - increased010020
Sodium decreased111101
Urate increased010000
SecondaryMaximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · µg/mL
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
µg/mLBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Cmax Hx-DR5-01 Cycle 1 (Day 1)0.86 ± 36.81.90 ± 38.02.81 ± 28.99.79 ± 20.921.31 ± 24.629.75 ± 24.9
Cmax Hx-DR5-01 Cycle 2 (Day 1)0.79 ± 42.92.11 ± 18.31.12 ± 59.98.36 ± 22.713.13 ± 156.329.56 ± 7.7
Cmax Hx-DR5-01 Cycle 3 (Day 1)0.89 ± 16.61.82 ± 53.90.89 ± 146.47.20 ± 11.220.35 ± 24.728.80 ± NA
Cmax Hx-DR5-05 Cycle 1 (Day 1)0.87 ± 45.21.81 ± 35.72.82 ± 31.89.72 ± 17.020.90 ± 21.929.44 ± 27.9
Cmax Hx-DR5-05 Cycle 2 (Day 1)0.79 ± 25.92.00 ± 18.31.11 ± 76.27.75 ± 25.820.37 ± 14.330.52 ± 5.8
Cmax Hx-DR5-05 Cycle 3 (Day 1)0.87 ± 26.61.28 ± 93.81.62 ± 108.26.77 ± 20.65.27 ± 577.828.50 ± NA
SecondaryArea Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · µg*h/mL
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
µg*h/mLBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
AUC(0-inf) Hx-DR5-01 Cycle 1 Day 139.44 ± 50.291.20 ± 66.085.80 ± 56.7523.66 ± 47.51298.0 ± 22.71497.7 ± 58.7
AUC(0-inf) Hx-DR5-01 Cycle 2 Day 146.37 ± 61.5105.32 ± 55.835.24 ± 30.5530.48 ± 24.81071.5 ± 30.72488.5 ± 10.7
AUC(0-inf) Hx-DR5-01 Cycle 3 Day 137.43 ± 74.053.24 ± 133.341.41 ± 84.9422.32 ± 26.81097.8 ± 36.62653.5 ± NA
AUC(0-inf) Hx-DR5-05 Cycle 1 Day 132.97 ± 55.471.21 ± 66.983.37 ± 51.7508.76 ± 33.01052.1 ± 24.71270.0 ± 60.1
AUC(0-inf) Hx-DR5-05 Cycle 2 Day 139.31 ± 65.993.11 ± 66.644.76 ± 184.4414.90 ± 24.1609.90 ± 55.22273.6 ± 9.0
AUC(0-inf) Hx-DR5-05 Cycle 3 Day 125.87 ± 57.351.36 ± 161.667.23 ± 200.5231.49 ± 53.2412.87 ± 64.12398.5 ± NA
SecondaryArea Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · µg*h/mL
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
µg*h/mLBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
AUC(0-Clast) Hx-DR5-01 Cycle 1 Day 124.36 ± 73.272.25 ± 70.660.78 ± 35.8460.37 ± 43.51173.7 ± 15.61058.9 ± 88.6
AUC(0-Clast) Hx-DR5-01 Cycle 2 Day 117.34 ± 141.370.33 ± 66.421.85 ± 36.0308.74 ± 66.8582.57 ± 84.82291.4 ± 18.1
AUC(0-Clast) Hx-DR5-01 Cycle 3 Day 122.34 ± 85.935.31 ± 151.46.85 ± 995.0385.54 ± 23.7986.38 ± 30.12444.7 ± NA
AUC(0-Clast) Hx-DR5-05 Cycle 1 Day 125.41 ± 120.753.76 ± 77.053.80 ± 50.8432.18 ± 24.5956.02 ± 18.8964.48 ± 91.1
AUC(0-Clast) Hx-DR5-05 Cycle 2 Day 124.85 ± 119.460.75 ± 76.029.17 ± 165.1258.67 ± 60.5395.50 ± 62.32176.0 ± 11.7
AUC(0-Clast) Hx-DR5-05 Cycle 3 Day 120.12 ± 168.716.95 ± 539.443.56 ± 405.4158.98 ± 76.452.16 ± 22162.52248.1 ± NA
SecondaryTotal Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

The CL of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · mL/h
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
mL/hBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
CL Hx-DR5-01 Cycle 1 Day 195.98 ± 53.891.27 ± 51.4123.75 ± 69.965.36 ± 56.559.07 ± 31.469.50 ± 51.0
CL Hx-DR5-01 Cycle 2 Day 177.36 ± 70.279.97 ± 51.8155.76 ± 72.658.07 ± 31.873.43 ± 28.036.92 ± 2.0
CL Hx-DR5-01 Cycle 3 Day 199.53 ± 57.1131.46 ± 76.0111.33 ± 12.962.90 ± 42.562.64 ± 26.137.87 ± NA
CL Hx-DR5-05 Cycle 1 Day 1111.10 ± 62.5116.89 ± 51.3127.35 ± 69.367.28 ± 37.469.39 ± 29.281.96 ± 53.9
CL Hx-DR5-05 Cycle 2 Day 190.18 ± 69.490.45 ± 67.1131.51 ± 240.779.72 ± 28.8134.11 ± 51.940.41 ± 3.7
CL Hx-DR5-05 Cycle 3 Day 1143.09 ± 50.5140.38 ± 77.368.57 ± 42.2114.74 ± 59.8172.66 ± 78.941.90 ± NA
SecondaryVolume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05

The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · mL
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
mLBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Vss Hx-DR5-01 Cycle 1 Day 15366.8 ± 35.04788.6 ± 5.03666.8 ± 49.43834.6 ± 34.34885.9 ± 18.84127.3 ± 19.2
Vss Hx-DR5-01 Cycle 2 Day 14720.0 ± 34.94287.5 ± 10.55283.0 ± 62.03998.1 ± 24.04185.8 ± 17.33427.5 ± 25.1
Vss Hx-DR5-01 Cycle 3 Day 14622.7 ± 31.14531.9 ± 6.73243.6 ± 14.34075.3 ± 26.24227.1 ± 8.74118.5 ± NA
Vss Hx-DR5-05 Cycle 1 Day 14722.7 ± 55.65242.9 ± 15.83942.4 ± 63.63611.0 ± 26.54291.6 ± 9.84142.9 ± 21.0
Vss Hx-DR5-05 Cycle 2 Day 14899.3 ± 22.74701.6 ± 15.05177.9 ± 100.64054.4 ± 16.44334.9 ± 14.93187.8 ± 41.0
Vss Hx-DR5-05 Cycle 3 Day 14812.5 ± 31.95077.6 ± 24.13577.1 ± 15.74951.2 ± 42.45130.8 ± 5.64173.9 ± NA
SecondaryHalf-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Median · h
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
hBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
T1/2 Hx-DR5-01 Cycle 1 Day 141.69 (20.7 to 61.1)41.31 (16.6 to 60.3)18.10 (11.4 to 40.5)40.27 (5.1 to 66.8)70.90 (50.5 to 86.2)42.45 (17.9 to 80.5)
T1/2 Hx-DR5-01 Cycle 2 Day 137.75 (29.1 to 72.3)39.57 (21.7 to 62.5)24.47 (16.9 to 29.7)49.64 (36.2 to 71.5)33.62 (29.0 to 88.2)65.85 (54.6 to 77.1)
T1/2 Hx-DR5-01 Cycle 3 Day 127.64 (16.2 to 84.1)19.93 (13.1 to 66.9)20.16 (16.2 to 24.1)47.86 (30.8 to 60.0)44.51 (40.1 to 64.0)77.00 (77.00 to 77.00)
T1/2 Hx-DR5-05 Cycle 1 Day 135.55 (12.5 to 46.5)34.50 (15.6 to 52.5)19.10 (14.6 to 44.0)36.33 (26.4 to 70.6)42.68 (35.3 to 68.8)37.71 (16.6 to 69.6)
T1/2 Hx-DR5-05 Cycle 2 Day 132.46 (19.3 to 71.4)37.71 (17.3 to 80.7)25.43 (13.9 to 62.3)37.69 (28.4 to 43.5)26.68 (13.1 to 29.4)51.97 (30.8 to 73.1)
T1/2 Hx-DR5-05 Cycle 3 Day 125.30 (12.0 to 39.6)18.75 (15.4 to 57.4)41.26 (24.3 to 58.2)33.90 (14.2 to 62.1)22.83 (13.2 to 32.5)70.9 (70.9 to 70.9)
SecondaryTime to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Median · h
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
h1. Biweekly Regimen (GEN1029 0.1 mg/kg)2. Biweekly Regimen (GEN1029 0.2 mg/kg)3. Biweekly Regimen (GEN1029 0.3 mg/kg)4. Biweekly Regimen (GEN1029 1.0 mg/kg)5. Biweekly Regimen (GEN1029 2.0 mg/kg)6. Biweekly Regimen (GEN1029 3.0 mg/kg)
Tmax Hx-DR5-01 Cycle 1 Day 11.58 (1.1 to 5.8)1.89 (1.4 to 5.0)1.23 (1.2 to 1.4)2.00 (0.1 to 4.7)1.30 (1.1 to 3.6)1.46 (1.0 to 3.1)
Tmax Hx-DR5-01 Cycle 2 Day 11.25 (1.0 to 3.2)3.03 (3.0 to 5.2)1.30 (1.1 to 3.2)3.06 (1.1 to 5.1)3.25 (1.1 to 163.7)1.11 (1.0 to 1.2)
Tmax Hx-DR5-01 Cycle 3 Day 11.08 (0.0 to 3.4)1.48 (1.0 to 2.1)1.13 (1.1 to 1.3)3.08 (1.4 to 3.5)1.82 (1.1 to 3.2)3.1 (3.1 to 3.1)
Tmax Hx-DR5-05 Cycle 1 Day 11.75 (1.1 to 5.4)2.53 (1.0 to 4.8)2.36 (1.2 to 5.5)1.60 (0.1 to 4.7)1.35 (1.1 to 3.0)1.46 (1.0 to 3.1)
Tmax Hx-DR5-05 Cycle 2 Day 13.12 (1.1 to 5.1)2.19 (1.0 to 3.5)1.19 (1.0 to 1.4)2.26 (1.2 to 5.1)2.31 (1.1 to 3.3)2.21 (1.2 to 3.2)
Tmax Hx-DR5-05 Cycle 3 Day 11.08 (0.0 to 1.5)1.83 (1.0 to 3.3)1.18 (1.1 to 1.3)1.42 (1.1 to 3.0)1.13 (1.0 to 1.8)3.1 (3.1 to 3.1)
SecondaryPlasma Concentration of Hx-DR5-01 and Hx-DR5-05

The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.

Time frame:
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Reported as:
Geometric mean · µg/mL
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
µg/mLBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Plasma concentration Hx-DR5-01 Cycle 1 Day 1 (predose)0.085 ± 38.50.075 ± 0.00.075 ± 0.00.075 ± 0.00.075 ± 0.00.075 ± 0.0
Plasma concentration Hx-DR5-01 Cycle 2 Day 1 (predose)0.091 ± 61.00.075 ± 0.00.075 ± 0.00.084 ± 34.00.230 ± 77.80.283 ± 576.2
Plasma concentration Hx-DR5-01 Cycle 3 Day 1 (predose)0.075 ± 0.00.125 ± 164.30.075 ± 0.00.090 ± 46.40.224 ± 156.90.739 ± NA
Plasma concentration Hx-DR5-05 Cycle 1 Day 1 (predose)0.094 ± 77.60.075 ± 0.00.075 ± 0.00.075 ± 0.00.075 ± 0.00.075 ± 0.0
Plasma concentration Hx-DR5-05 Cycle 2 Day 1 (predose)0.097 ± 83.60.075 ± 0.00.075 ± 0.00.075 ± 0.00.155 ± 161.50.240 ± 372.5
Plasma concentration Hx-DR5-05 Cycle 3 Day 1 (predose)0.101 ± 94.60.119 ± 138.50.075 ± 0.00.094 ± 58.80.075 ± 0.00.568 ± NA
SecondaryNumber of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.

Time frame:
From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
Reported as:
Count of participants · Participants
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
ParticipantsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029554750
SecondaryChange From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.

Time frame:
From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
Reported as:
Mean · millimeter
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
millimeterBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage12.0 ± 11.84312.0 ± 17.61613.75 ± 9.0321.10 ± 9.0499.0 ± 10.90915.50 ± 18.574
SecondaryNumber of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.

Time frame:
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Reported as:
Count of participants · Participants
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ParticipantsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1000000
SecondaryProgression-Free Survival (PFS) According to RECIST 1.1

The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.

Time frame:
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Reported as:
Median · months
Progression-Free Survival (PFS) According to RECIST 1.1
monthsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Progression-Free Survival (PFS) According to RECIST 1.12.5 (0.5 to 3.9)1.4 (0.5 to NA)2.4 (0.8 to NA)1.9 (1.2 to NA)1.2 (1.1 to NA)1.2 (1.0 to NA)
SecondaryOverall Survival (OS) According to RECIST 1.1

Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.

Time frame:
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Reported as:
Median · months
Overall Survival (OS) According to RECIST 1.1
monthsBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)
Overall Survival (OS) According to RECIST 1.17.0 (2.3 to NA)6.4 (1.8 to NA)4.9 (NA to NA)7.1 (1.7 to NA)4.7 (2.8 to NA)6.9 (NA to NA)
SecondaryDuration of Response (DoR) According to RECIST 1.1

The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.

Time frame:
From Day 1 through 8.8 months (corresponding to maximum observed duration)

No measurements were reported for this outcome.

SecondaryTime to Response (TTR) According to RECIST 1.1

TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.

Time frame:
From Day 1 through 8.8 months (corresponding to maximum observed duration)

No measurements were reported for this outcome.

Adverse events

Collected over For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Biweekly Regimen (GEN1029 0.1 mg/kg)3/10 (30%)3/10 (30%)8/10 (80%)
Biweekly Regimen (GEN1029 0.2 mg/kg)3/7 (42.9%)3/7 (42.9%)7/7 (100%)
Biweekly Regimen (GEN1029 0.3 mg/kg)1/4 (25%)2/4 (50%)4/4 (100%)
Biweekly Regimen (GEN1029 1.0 mg/kg)5/11 (45.5%)9/11 (81.8%)11/11 (100%)
Biweekly Regimen (GEN1029 2.0 mg/kg)4/7 (57.1%)6/7 (85.7%)7/7 (100%)
Biweekly Regimen (GEN1029 3.0 mg/kg)1/7 (14.3%)4/7 (57.1%)7/7 (100%)
Priming Regimen (GEN1029 0.1 mg/kg)0/1 (0%)0/1 (0%)1/1 (100%)
Intensified Regimen (GEN1029 1.0 mg/kg)1/1 (100%)1/1 (100%)1/1 (100%)
Most frequent serious events
Showing 10 of 32
Most frequent serious events
EventBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)
Drug-Induced Liver InjuryHepatobiliary disorders0/100/70/41/110/70/70/11/1
DiarrhoeaGastrointestinal disorders0/100/70/41/113/71/70/10/1
Alanine Aminotransferase IncreasedInvestigations1/101/71/41/110/73/70/10/1
Aspartate Aminotransferase IncreasedInvestigations1/101/71/41/110/72/70/10/1
Malignant Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/102/70/43/111/70/70/10/1
Sinus TachycardiaCardiac disorders0/100/71/40/110/70/70/10/1
PyrexiaGeneral disorders0/100/71/42/111/71/70/10/1
HyperbilirubinaemiaHepatobiliary disorders0/100/71/40/110/70/70/10/1
Tinea VersicolourInfections and infestations0/100/71/40/110/70/70/10/1
EnteritisGastrointestinal disorders0/100/70/40/111/70/70/10/1
Most frequent other events
Showing 10 of 131
Most frequent other events
EventBiweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)
AnaemiaBlood and lymphatic system disorders2/102/71/43/112/71/71/10/1
Ear painEar and labyrinth disorders0/100/70/40/110/70/71/10/1
DiarrhoeaGastrointestinal disorders1/101/70/43/114/72/70/11/1
NauseaGastrointestinal disorders2/100/70/41/113/71/71/10/1
FatigueGeneral disorders4/100/71/45/112/71/71/10/1
PainGeneral disorders0/100/70/40/110/70/71/10/1
HyperbilirubinaemiaHepatobiliary disorders0/100/71/41/111/70/70/11/1
Alanine aminotransferase increasedInvestigations3/103/72/46/113/72/71/11/1
Aspartate aminotransferase increasedInvestigations4/104/72/47/114/73/70/11/1
DehydrationMetabolism and nutrition disorders1/100/71/41/110/70/71/10/1

Baseline characteristics

Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.

Age, Categorical
Age, Categorical(Participants)Biweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)Total
<=18 years000000000
Between 18 and 65 years7327341027
>=65 years3424430121
Sex: Female, Male
Sex: Female, Male(Participants)Biweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)Total
Female6128541027
Male4623230121
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Biweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)Total
Hispanic or Latino011111005
Not Hispanic or Latino106310661143
Unknown or Not Reported000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Biweekly Regimen (GEN1029 0.1 mg/kg)Biweekly Regimen (GEN1029 0.2 mg/kg)Biweekly Regimen (GEN1029 0.3 mg/kg)Biweekly Regimen (GEN1029 1.0 mg/kg)Biweekly Regimen (GEN1029 2.0 mg/kg)Biweekly Regimen (GEN1029 3.0 mg/kg)Priming Regimen (GEN1029 0.1 mg/kg)Intensified Regimen (GEN1029 1.0 mg/kg)Total
American Indian or Alaska Native000000000
Asian100000001
Native Hawaiian or Other Pacific Islander000000000
Black or African American120000003
White85311771143
More than one race000000000
Unknown or Not Reported001000001
08

Study locations

6 sites
  • Yale University
    New Haven, Connecticut 06510, United States
  • UT M.D Anderson Cancer Center
    Houston, Texas 77030, United States
  • Hospital Univeritario Vall d'Hebron
    Barcelona, Spain
  • START Madrid CIOCC
    Madrid, Spain
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle, United Kingdom
  • The Royal Mardsen NHS Foundation Trust
    Sutton, United Kingdom
09

References and documents

Study documents

  • Study protocol · Oct 24, 2019
  • Statistical analysis plan · Mar 7, 2022

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03576131
Lead sponsor
Genmab
Responsible party
Sponsor
First posted
Jul 3, 2018
Start date
Apr 30, 2018
Primary completion
Oct 12, 2021
Completion
Oct 12, 2021
Results posted
Dec 12, 2022
Last update
Aug 1, 2023

Study contacts

Ruth Plummer, Professor
principal investigator · Newcastle Hospitals NHS Foundation Trust

Oversight

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

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