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

Recruiting now · Phase 1/Phase 2

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT05579366

Run by

Genmab

People needed

884

Starts

2022-12-07

Expected to finish

2027-10-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.
• Part C, E, and H:
• 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 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.
• Part D:
• Cohort D1:
• Participants must have platinum-sensitive ovarian cancer.
• Participants must have received 1 to 3 prior lines of therapy.
• Cohort D2:
• 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.
• Cohort D3:
• Endometrial cancer (any subtype excluding sarcoma).
• Cohort D4:
• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

You may not qualify if…

• 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.
• Note: Other protocol-defined inclusion/exclusion may apply.

Where it is running

• USOR Arizona Oncology Associates — Tucson, Arizona, United States (enrolling)
• University of California Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• University of California, San Diego; Moores Cancer Center — San Diego, California, United States (enrolling)
• USOR Sansum Clinic — Santa Barbara, California, United States (enrolling)
• Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
• USOR Florida Cancer Specialists South — Fort Myers, Florida, United States (enrolling)
• USOR Florida Cancer Specialists North — St. Petersburg, Florida, United States (enrolling)
• USOR Florida Cancer Specialists East — West Palm Beach, Florida, United States (enrolling)
• Augusta University Georgia Cancer Center — Augusta, Georgia, United States (enrolling)
• University of Kansas Medical Center (KUMC) — Westwood, Kansas, United States (enrolling)
• USOR Maryland Oncology Hematology — Rockville, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• USOR Minnesota Oncology Hematology — Maplewood, Minnesota, United States (enrolling)
• MD Anderson Cancer Center at Cooper- Two Cooper Plaza — Camden, New Jersey, United States (enrolling)
• Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (enrolling)
• University of Oklahoma - Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• USOR Oncology Associates of Oregon, P.C. — Eugene, Oregon, United States (enrolling)
• Compass Oncology - Rose Quarter — Portland, Oregon, United States (enrolling)
• USOR Alliance Cancer Specialist — Doylestown, Pennsylvania, United States (enrolling)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)
• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States (enrolling)
• USOR HonorHealth — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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