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

• Status: Completed
• Trial end date: 2020-05-24
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Paclitaxel; Ramucirumab

Criteria

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).