Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
NCT05579366 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 764
Last updated 2026-04-07
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).
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
- DRUG
-
Rina-S
Intravenous infusion of Rina-S
- DRUG
-
Carboplatin intravenous infusion
- DRUG
-
Bevacizumab intravenous infusion
- DRUG
-
Pembrolizumab intravenous infusion
Sponsors & Collaborators
-
Genmab
lead INDUSTRY
Principal Investigators
-
Study Official · Genmab
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-07
- Primary Completion
- 2027-07-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
- China
- Japan
Study Locations
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