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OncoMatch/Clinical Trials/NCT05579366

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

Is NCT05579366 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Rina-S and Carboplatin for high grade epithelial ovarian cancer.

Phase 1/2RecruitingGenmabNCT05579366Data as of May 2026

Treatment: Rina-S · Carboplatin · Bevacizumab · PembrolizumabThis 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).

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Endometrial Cancer

Non-Small Cell Lung Carcinoma

Mesothelioma

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Required: EGFR mutation

EGFR-mutated NSCLC (Part B)

Allowed: 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) 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.

Allowed: 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) 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.

Disease stage

Metastatic disease required

Prior therapy

Max 4 prior lines
Min 1 prior line

Must have received: platinum-based chemotherapy

Participants must have received prior platinum-based chemotherapy

Must have received: bevacizumab or approved biosimilar

Participants must have received prior bevacizumab or approved biosimilar

Must have received: PARP inhibitor — maintenance

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 ... 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 →

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