Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors
Genmab
Summary
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
Description
This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. The study consists of multiple parts: Part A: monotherapy cohorts Part B: tumor-specific monotherapy dose-expansion cohorts Part C: platinum-resistant ova…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Part A and B: * Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B). * Previously received therapies known to confer clinical benefit. * Measurable disease per RECIST v1.1 for all tumor types other than pleural me…
Interventions
- DrugRina-S
Intravenous infusion of Rina-S
- DrugCarboplatin
Carboplatin intravenous infusion
- DrugBevacizumab
Bevacizumab intravenous infusion
- DrugPembrolizumab
Pembrolizumab intravenous infusion
Locations (66)
- USOR HonorHealthPhoenix, Arizona
- USOR Arizona Oncology AssociatesTucson, Arizona
- University of California Los Angeles Medical CenterLos Angeles, California
- University of California, San Diego; Moores Cancer CenterSan Diego, California
- USOR Sansum ClinicSanta Barbara, California
- Providence Medical FoundationSanta Rosa, California