Rinatabart Sesutecan (Rina-S) for Advanced Solid Tumors
This study is testing a drug called Rinatabart Sesutecan (Rina-S) for people with advanced solid tumors, including certain types of ovarian, fallopian tube, primary peritoneal, and endometrial cancers. Researchers want to learn about the safety and side effects of Rina-S, and how well it works. Some parts of the study will also look at Rina-S combined with other drugs like Carboplatin, Bevacizumab, or Pembrolizumab. The study aims to see if Rina-S can shrink tumors or stop their growth. You may be eligible if you have a solid tumor that has spread or cannot be removed by surgery. The study is currently recruiting, but the exact status is unclear.
- Study design
- This is a Phase 1/2 interventional study, meaning it's in early stages of testing. It plans to enroll about 884 participants and has multiple parts, some testing Rina-S alone and others in combination with other drugs.
- What's involved
- You would receive Rinatabart Sesutecan (Rina-S) as an intravenous infusion, and potentially other drugs depending on the study part. Treatment continues until your disease gets worse, side effects are too severe, or other reasons.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects and how well the treatment works for up to approximately one year after treatment ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05579366
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Recruiting
PHASE1Ages 18+InterventionalTreatmentGenmab
~884 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Rina-SCarboplatinBevacizumabPembrolizumab
At a glance
Recruiting sites
66 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Measured over Through end of treatment, up to approximately 1 year.
+3 more outcomes measured
Conditions
Where it's being run
66 sites across 37 statesChina8
Texas6
California4
Shanghai Municipality4
Florida3
Arizona2
Massachusetts2
Michigan2
Study leadership
- Study Official · STUDY_DIRECTOR · Genmab
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 mesothelioma which will use mRECIST v1.1 at baseline.
High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
Participants must have platinum-resistant ovarian cancer.
Participants must have received prior bevacizumab or approved biosimilar.
Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \[FDA\]-approved test in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
Measurable disease per the RECIST v1.1 at baseline.
Participants must have platinum-sensitive ovarian cancer.
Participants must have received 1 to 3 prior lines of therapy.
Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.
Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.
Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\>183 days) or more from the last dose of platinum-based therapy.
Participants must have histologically or cytologically confirmed EC.
Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:
Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\[L\])1 inhibitor.
Participants who progress \>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
Measurable disease per the RECIST Version 1.1 at baseline.
Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).
Participants must have platinum sensitive ovarian cancer.
Measurable disease per the RECIST Version 1.1 at baseline.
Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.
Measurable disease per the RECIST Version 1.1 at baseline.
Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).
Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
Measurable disease per the RECIST Version 1.1 at baseline.
Exclusion
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
What this trial measures
- Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]Through end of treatment, up to approximately 1 year.
- Parts A, and D - Dose Limiting Toxicity (DLT)At the end of Cycle 1 (each cycle is 21 days)
The proportion of participants experiencing DLT.
- Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Through end of treatment, up to approximately 1 year.
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
- Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by HolterCycles 1 to 3 (each cycle is 21 days)