NCT05579366

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

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 764 (estimated)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 ovarian cancer (PROC) monotherapy cohort Part D: combination therapy cohorts Parts F and G: a monotherapy endometrial cancer (EC) cohort Part H: a monotherapy PROC cohort Part I: platinum-sensitive ovarian cancer (PSOC) cohort Part J: a monotherapy PROC cohort Part K: a monotherapy high-grade ovarian cancer cohort Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Conditions

• High Grade Epithelial Ovarian Cancer
• High Grade Serous Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer
• Endometrial Cancer
• Non-small Cell Lung Cancer
• Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)
• Mesothelioma
• Breast Adenocarcinoma
• Triple Negative Breast Cancer
• Hormone Receptor-positive/Her2 Negative Breast Cancer
• Platinum-resistant Ovarian Cancer (PROC)
• Platinum Sensitive Ovarian Cancer (PSOC)
• Primary Refractory Ovarian Cancer
• Uterine Cancer

Interventions

Type	Name	Description
DRUG	Rina-S	Intravenous infusion of Rina-S
DRUG	Carboplatin	Carboplatin intravenous infusion
DRUG	Bevacizumab	Bevacizumab intravenous infusion
DRUG	Pembrolizumab	Pembrolizumab intravenous infusion

Timeline

• Start date: 2022-12-07
• Primary completion: 2027-07-01
• Completion: 2027-10-01
• First posted: 2022-10-13
• Last updated: 2026-04-07

Locations

66 sites across 3 countries: United States, China, Japan

Regulatory

• FDA-regulated drug study