OncoMatch/Clinical Trials/NCT05579366
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Official title: Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors
Is NCT05579366 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for high grade epithelial ovarian cancer.
Treatment: Rina-S · Carboplatin · Bevacizumab · Pembrolizumab · Erythromycin · Itraconazole — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Ovarian Cancer
Endometrial Cancer
Non-Small Cell Lung Carcinoma
Mesothelioma
Breast Carcinoma
Triple-Negative Breast Cancer
Cervical Cancer
Biomarker criteria
Required: EGFR mutation
EGFR-mutated NSCLC (Part B)
Required: BRCA1 deleterious germline or somatic mutation
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)
Required: BRCA2 deleterious germline or somatic mutation
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)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
Participants must have received prior platinum-based chemotherapy
Must have received: bevacizumab or approved biosimilar (bevacizumab)
Participants must have received prior bevacizumab or approved biosimilar
Must have received: PARP inhibitor — maintenance
Participants with known or suspected deleterious germline or somatic BRCA mutations ... 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
Must have received: programmed death-ligand 1 (PD-L1) inhibitor
Participants must have received prior ... a programmed death-ligand 1 (PD-[L])1 inhibitor
Cannot have received: topoisomerase 1 inhibitor-based antibody drug conjugate
Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USOR HonorHealth · Phoenix, Arizona
- USOR Arizona Oncology Associates · Tucson, Arizona
- University of California Los Angeles Medical Center · Los Angeles, California
- University of California, San Diego; Moores Cancer Center · San Diego, California
- USOR Sansum Clinic · Santa Barbara, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05579366 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase 1 inhibitor-based antibody drug conjugate disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Does this trial require BRCA1?
Yes, BRCA1 deleterious germline or somatic mutation is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 deleterious germline or somatic mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify