Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 1  | ENROLLING

NCT04557384

Advanced Solid Tumors

VEGF Receptor-2 Antagonist


A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors*

NCT04557384
Key Inclusion Criteria
  • Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Appropriate candidate for experimental therapy and exhausted all anticancer treatments with proven clinical benefit; have hepatocellular carcinoma or gastric cancer and have received prior treatment, and intravenous (IV) ramucirumab monotherapy is clinically acceptable treatment after progression; or have a diagnosis for which IV ramucirumab in combination with additional anticancer therapy is clinically acceptable treatment (cohorts B and C only)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Discontinued all previous treatments for cancer with adequate wash-out period and recovered from the acute effects of therapy
  • Adequate hematologic, hepatic, and renal functions and electrolytes
  • Males and females of child-bearing potential must agree to use highly effective contraceptive methods during study treatment and for 5 months following the last dose of study drug
Key Exclusion Criteria
  • Uncontrolled hypertension defined as systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg despite standard medical management
  • Significant bleeding disorders or experienced grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
  • Hepatic impairment (such as severe liver cirrhosis Child-Pugh B [or worse], cirrhosis with a history of hepatic encephalopathy, clinically meaningful ascites requiring ongoing treatment with diuretics and/or paracentesis, or history of hepatorenal syndrome)
  • Experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, ≤6 months prior to randomization
  • Clinically relevant congestive heart failure (New York Heart Association [NYHA] grade ≥2) or symptomatic or poorly controlled cardiac arrhythmia
  • Symptomatic central nervous system metastases
  • History of GI perforation and/or fistula within 6 months prior to enrollment
  • Active, uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing uncontrolled intercurrent illness
  • Serious or nonhealing wound, ulcer, or bone fracture within 4 weeks prior to enrollment
  • Prior IV ramucirumab treatment
*
This clinical trial is being conducted globally.
Ramucirumab is administered subcutaneously.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.