Clinical trial · Interventional
A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors
A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors
NCT02597036CI-TRIAL-00096760terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3127804 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part A LY3127804
- description
- 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.
- interventionNames
- Drug: LY3127804
- type
- EXPERIMENTAL
- label
- Part B LY3127804 + 8 mg/kg Ramucirumab
- description
- 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.
- interventionNames
- Drug: LY3127804
- Drug: Ramucirumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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).
References
Publications (1)
- DERIVEDMartin-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. PMID 32741971