Rinatabart Sesutecan (Rina-S) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
About the study
Who can take part
INCLUSION CRITERIA
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.
- 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.
Part C:
Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.
- 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 1 to 3 prior lines of therapy. Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was the last line of therapy.
- Participants must have platinum-resistant ovarian cancer.
- Participants must have received prior bevacizumab.
- 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) 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.
- Participants must have known FRα status based on an FDA approved test. Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.
- Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment.
- A switch/change in regimen due solely to toxicity or participant preference (and not disease progression) is not considered a separate line of therapy.
Part D:
Cohort D1 (Rina-S+carboplatin):
- Participants must have platinum-sensitive ovarian cancer.
- Participants must have received 1 to 3 prior lines of therapy.
Cohort D2 (Rina-S+bevacizumab):
- Participants must have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
- 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.
Cohort D3 (Rina-S+pembrolizumab):
- Endometrial cancer (any subtype excluding sarcoma).
- Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.
EXCLUSION CRITERIA
Exclusion Criteria:
- 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.
- Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalation only).
- Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
Note: Other protocol-defined inclusion/exclusion may apply.

Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Study Details
Contition
Platinum-Resistant Ovarian Cancer,Platinum Sensitive Ovarian Cancer (PSOC),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
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
404
Est. Completion Date
Oct 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Genmab
ClinicalTrials.gov NCT Identifier
NCT05579366
Study Number
PRO1184-001
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?