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Recruiting Phase 1/2

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

NCT05579366 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 1/2
Started
2022-12-07
Last updated
2026-10-07

Condition(s) studied

High Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerEndometrial CancerNon-small Cell Lung CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)MesotheliomaBreast AdenocarcinomaTriple Negative Breast CancerHormone Receptor-positive/Her2 Negative Breast CancerPlatinum-resistant Ovarian Cancer (PROC)Platinum Sensitive Ovarian Cancer (PSOC)Primary Refractory Ovarian CancerUterine CancerCervical Cancer

Investigational drug(s) / intervention(s)

Rina-S →Carboplatin →Bevacizumab →Pembrolizumab →Erythromycin →Itraconazole →

Rina-S: Intravenous infusion of Rina-S

Carboplatin: Carboplatin intravenous infusion

Bevacizumab: Bevacizumab intravenous infusion

Pembrolizumab: Pembrolizumab intravenous infusion

Erythromycin: Erythromycin oral administration

Itraconazole: Itraconazole oral administration

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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). Cohort D5 • Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors). Part F and G: * 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. Part I: * 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. Part J: * 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. Part K: * 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. Part L: * Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented. * Participants must either have 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), or * NSCLC. * Age 18 to 65 years (inclusive). * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Measurable disease per the RECIST version 1.1 at baseline. 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. * Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate. Note: Other protocol-defined inclusion/exclusion may apply.

Primary outcome measure(s)

  • 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 - Number of Participants with Dose Limiting Toxicity (DLT) — At the end of Cycle 1 (each cycle is 21 days)
  • 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) v1.1 — Through 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 Holter — Cycles 1 to 3 (each cycle is 21 days)
  • Part L - Peak Plasma Concentration (Cmax) of Rina-S — Cycles 1 and 2 (each cycle is 21 days)
    Measurement of maximum plasma concentration after the administration of Rina-S.\[
  • Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S — Cycles 1 and 2 (each cycle is 21 days)
    Measurement of AUC after the administration of Rina-S.

Trial sites (66)

FacilityCityRegionStatus
USOR HonorHealth Phoenix Arizona Recruiting
USOR Arizona Oncology Associates Tucson Arizona Recruiting
University of California Los Angeles Medical Center Los Angeles California Recruiting
University of California, San Diego; Moores Cancer Center San Diego California Recruiting
USOR Sansum Clinic Santa Barbara California Recruiting
Providence Medical Foundation Santa Rosa California Recruiting
USOR Florida Cancer Specialists South Fort Myers Florida Recruiting
USOR Florida Cancer Specialists North St. Petersburg Florida Recruiting
USOR Florida Cancer Specialists East West Palm Beach Florida Recruiting
Augusta University Georgia Cancer Center Augusta Georgia Recruiting
University of Kansas Medical Center (KUMC) Westwood Kansas Recruiting
USOR Maryland Oncology Hematology Rockville Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
START Midwest Grand Rapids Michigan Recruiting
USOR Minnesota Oncology Hematology Maplewood Minnesota Recruiting
MD Anderson Cancer Center at Cooper- Two Cooper Plaza Camden New Jersey Recruiting
Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute Columbus Ohio Recruiting
University of Oklahoma - Health Sciences Center Oklahoma City Oklahoma Recruiting
USOR Oncology Associates of Oregon, P.C. Eugene Oregon Recruiting
Compass Oncology - Rose Quarter Portland Oregon Recruiting
USOR Alliance Cancer Specialist Doylestown Pennsylvania Recruiting
Allegheny Health Network Pittsburgh Pennsylvania Recruiting
Women and Infants Hospital of Rhode Island Providence Rhode Island Recruiting
Sarah Cannon Research Institute at Tennessee Oncology Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
USOR Texas Oncology Abilene Texas Recruiting
Texas Oncology - Central / South Texas Austin Texas Recruiting
Mary Crowley Cancer Research Dallas Texas Recruiting
USOR Texas Oncology Fort Worth Texas Recruiting
Texas Oncology - Northeast TX Tyler Texas Recruiting
USOR Texas Oncology Gulf Coast Woodland Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
USOR Virginia Cancer Specialists Fairfax Virginia Recruiting
USOR Virginia Oncology Associates Norfolk Virginia Recruiting
Swedish Cancer Institute Everett Washington Recruiting
Cancer hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fujian China Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangdong China Recruiting

+ 26 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05579366 on ClinicalTrials.gov ↗ ← All trials in the USA