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TerminatedNCT02597036Updated Oct 23, 2025Results posted

A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors

A Phase 1 interventional study of LY3127804 and Ramucirumab in Solid Tumors, sponsored by Eli Lilly and Company. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-23.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel

02

Conditions studied

  • Solid Tumors

Keywords

  • Advanced, Angiopoietin
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Browse Eli Lilly and Company studies →

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

  • Have a diagnosis of cancer that is advanced and/or metastatic.
  • Have disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST ) version 1.1.
  • Have adequate organ function.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have discontinued previous treatments for cancer for at least 28 days or 5 half-lives prior to study enrolment.

Exclusion criteria

Exclusion Criteria:

  • Have serious preexisting medical conditions.
  • Have received treatment with a drug predominantly targeting Ang2 activity.
  • Have symptomatic central nervous system (CNS) malignancy or metastasis.
  • Have current hematologic malignancies.
  • Have an active fungal, bacterial, and/or known viral infection.
  • Have a corrected QT interval using Fridericia's correction (QTcF) of >470 msec on screening electrocardiogram (ECG) at several consecutive days of assessment.
  • Have a known sensitivity to mAbs or other therapeutic proteins.
  • Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
  • Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 3 months prior to receiving treatment.
  • Receive anticoagulation therapy at therapeutic dose.
  • Have experienced any arterial or venothrombotic or thromboembolic events within 6 months prior to study treatment.
  • Have liver cirrhosis with a Child-Pugh class B or worse or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
  • The participant is pregnant prior to randomization or breastfeeding.
  • The participant has sensory peripheral neuropathy ≥ Grade 2 (Part E only).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Part A LY3127804

    Participants received escalating doses of 4 milligram per kilogram (mg/kg), 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as intravenous (IV) infusion on days 1 and 15 of a 28-day cycle.

    Drug: LY3127804

  • Experimental
    Part B LY3127804 + 8 mg/kg Ramucirumab

    Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

    Drug: LY3127804 · Drug: Ramucirumab

  • Experimental
    Part C LY3127804 + 12 mg/kg Ramucirumab

    Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

    Drug: LY3127804 · Drug: Ramucirumab

  • Experimental
    Part D LY3127804 + Ramucirumab - Not Enrolled

    Participants were to receive LY3127804 and Ramucirumab IV Q2W until participant qualifies for study discontinuation. Part D and E were not enrolled based on the primary and secondary outcomes/ results of Part A-C.

    Drug: LY3127804 · Drug: Ramucirumab

  • Experimental
    Part E LY3127804 + Ramucirumab + Paclitaxel - Not Enrolled

    Participants were to receive LY3127804 and Ramucirumab IV Q2W and Paclitaxel IV on day 1, 8, and 15 until participant qualifies for study discontinuation. Part D and E were not enrolled based on the primary and secondary outcomes/ results of Part A-C.

    Drug: LY3127804 · Drug: Ramucirumab · Drug: Paclitaxel

Interventions

  • DrugLY3127804

    Administered IV

  • DrugRamucirumab

    Administered IV

    Also known as: LY3009806, Cyramza, 1121B

  • DrugPaclitaxel

    Administered IV

06

What researchers measure

Primary outcomes

  1. Recommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab

    Recommended Phase 2 dose was determined based on observed safety, pharmacokinetics (PK) and efficacy. However maximum tolerated dose (MTD) was not determined. For the purpose of this study, the MTD is defined as the highest tested dose in a single-agent setting that has less than (\<) 33% probability of causing a DLT. MTD in the combination setting was determined based on the nature and timing of the DLTs in the combination setting. Dose-limiting toxicities were not reported in any treatment cohort. Therefore, the maximum tolerated LY3127804 dose could not be determined.

    Time frame: Baseline through Cycle 1 (28 Day Cycle)

Secondary outcomes

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

    A dose limiting toxicity (DLT) defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>14 days; a DLT can be declared if a participant experiences increasing toxicity during treatment.

    Time frame: Baseline through Cycle 1 (28 Day Cycle)

  2. Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804

    Area under the plasma concentration-time curve of LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (h) was evaluated.

    Time frame: predose, end of infusion (1h), 2h, 24h, 96h, 168h, 336 h following dose on day 1 and at predose, end of infusion (1h), 24h, 168h and 336 h following dose on day 15 and at predose, end of infusion (1h), 2h, 168h, 336h following dose on day 29

  3. Pharmacokinetics: AUC of Ramucirumab in Combination With LY3127804

    Area under the serum concentration-time curve of ramucirumab in combination with LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) was evaluated following the first dose.

    Time frame: predose, end of infusion (1h), 24h, 96h, 168h, 336 h following Ramucirumab dose on day 1

  4. Number of Participants With Anti-LY3127804 Antibodies

    The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from cycle 1 pre-Dose through 30 days after last dose of study drug that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).

    Time frame: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up To 5 Months)

  5. Number of Participants With Anti-Ramucirumab Antibodies

    The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from cycle 1 pre-Dose through 30 days after last dose of study drug that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).

    Time frame: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up to 5 Months)

  6. Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

    ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.

    Time frame: Baseline through Measured Progressive Disease or Death (Up to 4 Months)

  7. Progression Free Survival (PFS)

    Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy.

    Time frame: Baseline to Measured Progressive Disease or Death (Up to 4 Months)

07

Results

Posted Oct 23, 2025
Limitations and caveats
No participants were enrolled in Part D and Part E reporting arms as these were deleted from protocol last amendment (based on the primary and secondary outcomes/ results of Part A-C).

Participant flow

Participant flow — Overall Study
MilestonePart A Cohort 1: 4 Milligram Per Kilogram (mg/kg) LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Started343334677787
Received at least 1 dose of study drug343334677787
Completed343323567665
Not completed000011110122
Withdrew: Progressive disease000011100000
Withdrew: Adverse event000000010001
Withdrew: Death000000000110
Withdrew: Lost to follow-up000000000010
Withdrew: Withdrawal by subject000000000001

Outcome measures

PrimaryRecommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab

Recommended Phase 2 dose was determined based on observed safety, pharmacokinetics (PK) and efficacy. However maximum tolerated dose (MTD) was not determined. For the purpose of this study, the MTD is defined as the highest tested dose in a single-agent setting that has less than (\<) 33% probability of causing a DLT. MTD in the combination setting was determined based on the nature and timing of the DLTs in the combination setting. Dose-limiting toxicities were not reported in any treatment cohort. Therefore, the maximum tolerated LY3127804 dose could not be determined.

Time frame:
Baseline through Cycle 1 (28 Day Cycle)
Reported as:
Number · milligram per kilogram (mg/kg)
Recommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab
milligram per kilogram (mg/kg)All Part A , Part B and Part C Participants
Recommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab20
SecondaryNumber of Participants With Dose Limiting Toxicities (DLTs)

A dose limiting toxicity (DLT) defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>14 days; a DLT can be declared if a participant experiences increasing toxicity during treatment.

Time frame:
Baseline through Cycle 1 (28 Day Cycle)
Reported as:
Number · participants
Number of Participants With Dose Limiting Toxicities (DLTs)
participantsPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Number of Participants With Dose Limiting Toxicities (DLTs)000000000000
SecondaryPharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804

Area under the plasma concentration-time curve of LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (h) was evaluated.

Time frame:
predose, end of infusion (1h), 2h, 24h, 96h, 168h, 336 h following dose on day 1 and at predose, end of infusion (1h), 24h, 168h and 336 h following dose on day 15 and at predose, end of infusion (1h), 2h, 168h, 336h following dose on day 29
Reported as:
Geometric mean · microgram*hour per milliliter(µg*hr/mL)
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804
microgram*hour per milliliter(µg*hr/mL)4 mg/kg LY31278048 mg/kg LY312780412 mg/kg LY312780416 mg/kg LY312780420 mg/kg LY312780427 mg/kg LY3127804
Day 1 dose11631 ± 3029817 ± 2533036 ± 3143636 ± 2557917 ± 2381931 ± 28
Day 15 dose16647 ± 3342486 ± 2247084 ± 3565837 ± 3985529 ± 22108015 ± 24
Day 29 dose16136 ± 2753889 ± 4162327 ± 2693032 ± 25106655 ± 28120607 ± 29
SecondaryPharmacokinetics: AUC of Ramucirumab in Combination With LY3127804

Area under the serum concentration-time curve of ramucirumab in combination with LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) was evaluated following the first dose.

Time frame:
predose, end of infusion (1h), 24h, 96h, 168h, 336 h following Ramucirumab dose on day 1
Reported as:
Geometric mean · µg*h/mL
Pharmacokinetics: AUC of Ramucirumab in Combination With LY3127804
µg*h/mLPart B Cohorts 2 to 6: LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Pharmacokinetics: AUC of Ramucirumab in Combination With LY312780420615 ± 3235403 ± 16
SecondaryNumber of Participants With Anti-LY3127804 Antibodies

The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from cycle 1 pre-Dose through 30 days after last dose of study drug that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).

Time frame:
Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up To 5 Months)
Reported as:
Number · participants
Number of Participants With Anti-LY3127804 Antibodies
participantsPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Number of Participants With Anti-LY3127804 Antibodies100100110110
SecondaryNumber of Participants With Anti-Ramucirumab Antibodies

The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from cycle 1 pre-Dose through 30 days after last dose of study drug that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).

Time frame:
Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up to 5 Months)
Reported as:
Number · participants
Number of Participants With Anti-Ramucirumab Antibodies
participantsPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12mg/kg LY3127804Part A Cohort 4: 16mg/kg LY3127804Part A Cohort 5: LY3127804-20mg/kgPart A Cohort 6: 27mg/kg LY3127804Part B Cohort 2: 8mg/kg LY3127804 + 8mg/kg RamucirumabPart B Cohort 3: 12mg/kg LY3127804 + 8mg/kg RamucirumabPart B Cohort 4: 16mg/kg LY3127804 + 8mg/kg RamucirumabPart B Cohort 5: 20mg/kg LY3127804 + 8mg/kg RamucirumabPart B Cohort 6: 27mg/kg LY3127804 + 8mg/kgPart C: 20mg/kg LY3127804 +12mg/kg Ramucirumab
Number of Participants With Anti-Ramucirumab Antibodies000000000000
SecondaryPercentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.

Time frame:
Baseline through Measured Progressive Disease or Death (Up to 4 Months)
Reported as:
Number · percentage of participants
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
percentage of participantsPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]0.0 (0.0 to 70.8)0.0 (0.0 to 60.2)0.0 (0.0 to 70.8)0.0 (0.0 to 70.8)0.0 (0.0 to 70.8)0.0 (0.0 to 60.2)33.3 (4.3 to 77.7)0.0 (0.0 to 41.0)0.0 (0.0 to 41.0)0.0 (0.0 to 41.0)12.5 (0.3 to 52.7)14.3 (0.4 to 57.9)
SecondaryProgression Free Survival (PFS)

Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy.

Time frame:
Baseline to Measured Progressive Disease or Death (Up to 4 Months)
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Progression Free Survival (PFS)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)

Adverse events

Collected over Baseline Up to 54 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A Cohort 1: 4 mg/kg LY31278040/3 (0%)0/3 (0%)3/3 (100%)
Part A Cohort 2: 8 mg/kg LY31278040/4 (0%)0/4 (0%)4/4 (100%)
Part A Cohort 3: 12 mg/kg LY31278041/3 (33.3%)0/3 (0%)3/3 (100%)
Part A Cohort 4: 16 mg/kg LY31278040/3 (0%)1/3 (33.3%)3/3 (100%)
Part A Cohort 5: 20 mg/kg LY31278041/3 (33.3%)0/3 (0%)3/3 (100%)
Part A Cohort 6: 27 mg/kg LY31278042/4 (50%)2/4 (50%)4/4 (100%)
Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab0/6 (0%)2/6 (33.3%)6/6 (100%)
Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab1/7 (14.3%)2/7 (28.6%)5/7 (71.4%)
Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab2/7 (28.6%)3/7 (42.9%)7/7 (100%)
Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab2/7 (28.6%)3/7 (42.9%)7/7 (100%)
Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab3/8 (37.5%)2/8 (25%)8/8 (100%)
Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab0/7 (0%)5/7 (71.4%)7/7 (100%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
Acute coronary syndromeCardiac disorders0/30/40/31/30/30/40/60/70/70/70/81/7
PyrexiaGeneral disorders0/30/40/30/30/31/40/60/70/70/70/80/7
Hip fractureInjury, poisoning and procedural complications0/30/40/30/30/31/40/60/70/70/70/80/7
Abdominal painGastrointestinal disorders0/30/40/30/30/30/41/60/70/71/70/80/7
Abdominal pain lowerGastrointestinal disorders0/30/40/30/30/30/41/60/70/70/70/80/7
Atrial fibrillationCardiac disorders0/30/40/30/30/30/40/60/71/70/70/80/7
Large intestinal obstructionGastrointestinal disorders0/30/40/30/30/30/40/60/71/71/70/80/7
HyperbilirubinaemiaHepatobiliary disorders0/30/40/30/30/30/40/61/70/70/70/80/7
Device related infectionInfections and infestations0/30/40/30/30/30/40/60/70/70/70/81/7
Mucosal infectionInfections and infestations0/30/40/30/30/30/40/60/70/71/70/80/7
Most frequent other events
Showing 10 of 155
Most frequent other events
EventPart A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg RamucirumabPart C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab
VomitingGastrointestinal disorders0/30/41/30/30/30/41/60/71/70/76/80/7
FatigueGeneral disorders0/31/40/30/30/33/43/60/72/71/74/81/7
ConstipationGastrointestinal disorders0/31/42/30/31/30/41/61/71/72/71/84/7
Oedema peripheralGeneral disorders1/30/40/30/31/32/42/62/73/74/74/82/7
HypertensionVascular disorders0/30/40/30/30/31/43/62/72/74/73/84/7
Abdominal painGastrointestinal disorders0/32/41/30/30/30/41/61/71/71/72/82/7
HeadacheNervous system disorders0/32/40/30/30/31/43/61/73/71/71/82/7
Abdominal distensionGastrointestinal disorders0/30/40/30/31/30/40/60/71/70/73/80/7
AscitesGastrointestinal disorders0/30/41/30/30/30/41/60/70/71/73/81/7
Abdominal pain lowerGastrointestinal disorders0/30/40/31/30/30/40/60/70/70/70/80/7

Baseline characteristics

All randomized participants in Part A, Part B and Part C.

Age, Continuous
Age, Continuous(years)Part A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg RamucirumabTotal
Mean56.30 ± 11.7254.30 ± 7.8058.70 ± 13.0566.00 ± 5.5766.00 ± 15.1362.80 ± 10.7257.80 ± 9.4155.30 ± 12.6551.90 ± 19.5865.60 ± 6.5350.60 ± 12.1154.40 ± 9.1357.30 ± 12.08
Sex: Female, Male
Sex: Female, Male(Participants)Part A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg RamucirumabTotal
Female12113331215326
Male22220136563436
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg RamucirumabTotal
Hispanic or Latino0000000000101
Not Hispanic or Latino12322436656545
Unknown or Not Reported22011031121216
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg RamucirumabTotal
American Indian or Alaska Native0000000000000
Asian0000000000000
Native Hawaiian or Other Pacific Islander0000000000000
Black or African American0000010030004
White14333367478756
More than one race0000000000000
Unknown or Not Reported2000000000002
Region of Enrollment
Region of Enrollment(participants)Part A Cohort 1: 4 mg/kg LY3127804Part A Cohort 2: 8 mg/kg LY3127804Part A Cohort 3: 12 mg/kg LY3127804Part A Cohort 4: 16 mg/kg LY3127804Part A Cohort 5: 20 mg/kg LY3127804Part A Cohort 6: 27 mg/kg LY3127804Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg RamucirumabPart B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kgPart C: 20 mg/kg LY3127804 +12 mg/kg RamucirumabTotal
Belgium01110213113115
France21111012320317
Spain01011021122112
United States11101221223218
08

Study locations

5 sites
  • SMO Sarah Cannon Research Inst.
    Nashville, Tennessee 37203, United States
  • Tennessee Oncology PLLC
    Nashville, Tennessee 37203, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Brussels, 1000, Belgium
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Villejuif, 94805, France
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Barcelona, 08035, Spain
09

References and documents

Publications

  • Martin-Liberal J, Hollebecque A, Aftimos P, Jungels C, Martin-Romano P, Rodon J, Kremer JD, Zhang W, Bendell J. First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. Br J Cancer. 2020 Oct;123(8):1235-1243. doi: 10.1038/s41416-020-1011-7. Epub 2020 Aug 3. PubMed 32741971 ↗

Study documents

  • Study protocol · Sep 11, 2017
  • Statistical analysis plan · Nov 15, 2017

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 Oct 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02597036
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Nov 6, 2015
Primary completion
Nov 23, 2017
Completion
May 24, 2020
Results posted
Oct 23, 2025
Last update
Oct 23, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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