Phase 12 Study Testing Rina-S for Advanced and Metastatic Solid Tumors Including Ovarian, Endometrial, Lung, Breast, and Mesothelioma Cancers

What this Trial Is About

Researchers are studying Rina-S, a drug designed to target folate receptor alpha, in people with advanced solid tumors that have either spread or cannot be removed by surgery. This Phase 12 trial aims to evaluate the safety, how the drug behaves in the body, and its antitumor activity. The study includes several parts focusing on specific cancers such as ovarian, endometrial, breast, lung cancers, mesothelioma, and cervical cancer, reflecting different patient groups and treatment approaches. Participants may receive Rina-S alone or combined with other drugs like carboplatin, bevacizumab, or pembrolizumab. Treatment continues until disease progression, unacceptable side effects, or other reasons such as withdrawal or study end. The study involves multiple cohorts, including those with platinum-resistant or platinum-sensitive ovarian cancer and endometrial cancer, with dosing and combination therapies tailored to these groups. During the trial, participants undergo regular assessments including imaging scans evaluated by standardized criteria, safety monitoring for side effects, and blood tests to study drug levels and immune responses. Outcomes measured include treatment side effects, tumor response rates, progression-free and overall survival, and pharmacokinetics. Participants may be followed for up to approximately two years to evaluate long-term effects and treatment responses.

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)