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

Last updated: March 3, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

1/2

Condition

Fallopian Tube Cancer

Non-small Cell Lung Cancer

Ovarian Cancer

Treatment

PRO1184

PRO1184 intravenous infusion of PRO1184

Carboplatin

Clinical Study ID

NCT05579366
GCT1184-01
GCT1184-01
PRO1184-001
CTR20230813
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Part A and B:

  • Histologically or cytologically confirmed metastatic or unresectable solidmalignancy including ovarian cancer (must have epithelial ovarian cancer, primaryperitoneal cancer, or fallopian tube cancer), endometrial cancer, non-small celllung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptorpositive, 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 pleuralmesothelioma 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 tubecancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, andthose 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) wasthe 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 ClinicalLaboratory Improvement Amendments [CLIA]-certified laboratory) and who achieved acomplete or partial response to platinum-based chemotherapy must have been treatedwith a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.

  • Participants must have known FRα status based on an FDA approved test. Those who areFRα positive must have previously received MIRV, unless the participant has adocumented medical exception.

  • Prior induction plus maintenance is considered 1 line of therapy, even if parts ofthe treatment regimen (induction or maintenance) are interrupted and/or resumed at alater date, in the absence of disease progression while on active treatment.

  • A switch/change in regimen due solely to toxicity or participant preference (and notdisease 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, orplatinum-sensitive ovarian cancer.

  • Participants must have received 1 to 3 prior lines of therapy for platinum-resistantovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitiveovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARPinhibitor, and MIRV.

Cohort D3 (Rina-S+pembrolizumab):

  • Endometrial cancer (any subtype excluding sarcoma).

  • Participants must have received prior platinum-based chemotherapy for recurrent oradvanced disease.

Exclusion

Exclusion Criteria:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired steroids within the past 2 years, has current ILD/pneumonitis, or wheresuspected ILD/pneumonitis cannot be ruled out by imaging at screening.

  • Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalationonly).

  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

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

Study Design

Total Participants: 404
Treatment Group(s): 6
Primary Treatment: PRO1184
Phase: 1/2
Study Start date:
December 07, 2022
Estimated Completion Date:
October 31, 2026

Study Description

This is a Phase 1/2 study of Rina-S; also known as GEN1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.

The study consists of multiple parts:

Part A: dose-escalation cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: platinum-resistant ovarian cancer (PROC) cohort

Part D: combination therapy cohorts

Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Connect with a study center

  • Cancer hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing
    China

    Active - Recruiting

  • Hunan Cancer Hospital - Phase 1

    Changsha, Hunan
    China

    Active - Recruiting

  • Hunan Cancer Hospital - Thoracic Medicine Dept II

    Changsha, Hunan
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Chang chun, Jilin
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center - Gynecologic Oncology

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center- Gynecology Onc

    Shanghai, Shanghai
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center- Phase 1

    Shanghai, Shanghai
    China

    Active - Recruiting

  • USOR HonorHealth

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • USOR Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • University of California Los Angeles Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Los Angeles Medical Center 106

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California, San Diego; Moores Cancer Center

    San Diego, California 92093
    United States

    Active - Recruiting

  • USOR Sansum Clinic

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • USOR Florida Cancer Specialists South

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • USOR Florida Cancer Specialists North

    Saint Petersburg, Florida 33709
    United States

    Active - Recruiting

  • USOR Florida Cancer Specialists East

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • University of Kansas Medical Center (KUMC)

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • USOR Maryland Oncology Hematology

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48085
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • USOR Minnesota Oncology Hematology

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • USOR Oncology Associates of Oregon, P.C.

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Compass Oncology - Rose Quarter

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Compass Oncology- Rose Quarter

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • USOR Alliance Cancer Specialist

    Doylestown, Pennsylvania 18901
    United States

    Active - Recruiting

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • USOR Texas Oncology

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Texas Oncology - Central / South Texas

    Austin, Texas 78758
    United States

    Active - Recruiting

  • Texas Oncology- Central/South Texas

    Austin, Texas 78758
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75521
    United States

    Active - Recruiting

  • USOR Texas Oncology

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Oncology - Northeast TX

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Texas Oncology-Northeast TX

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • USOR Texas Oncology Gulf Coast

    Woodland, Texas 77380
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • USOR Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • USOR Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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