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NCT05579366 | RECRUITING | High Grade Epithelial Ovarian Cancer

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

Genmab

Brief 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).

Condition or disease

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

Intervention/treatment

Rina-S

Carboplatin

Bevacizumab

Pembrolizumab

Phase

PHASE1

PHASE2

Detailed Description:

This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, 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: monotherapy cohorts Part B: tumor-specific monotherapy dose-expansion cohorts Part C: platinum-resistant ovarian cancer (PROC) cohort Part D: combination therapy cohorts Part F: a monotherapy endometrial cancer cohort 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 529 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors
Actual Study Start Date : 2022-12-07
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    • * 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
      • 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 1 to 3 prior lines of therapy. Participants who had 1 to 4 prior lines of therapy are allowed if mirvetuximab soravtansine (MIRV) was 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.
      • * 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) 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.
      • * Participants must have known FRα status based on an FDA approved test. Those who are FRα positive must have previously received MIRV, unless the participant has a documented medical exception.
      • * Participants who are FRα negative, in accordance with the FDA approved test (Ventana folate receptor \[FOLR1\] RxDx Assay), and were treated with MIRV, are excluded.
      • * Measurable disease per the RECIST v1.1 at baseline.
      • 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 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 (Rina-S+pembrolizumab)
              • * Endometrial cancer (any subtype excluding sarcoma).
              • * Participants must have received prior platinum-based chemotherapy for recurrent or advanced disease.
              • Part F
                • * Participants must have histologically or cytologically confirmed endometrial cancer as specified below.
                • * Advanced, recurrent, metastatic, or primary unresectable endometrial cancer (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma)
                • * Participants must have received 1 to 3 prior lines of therapy in advanced, recurrent, or metastatic setting, 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.
                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.
                • * Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 14 days (dose escalation only).
                • * Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
                • Note: Other protocol-defined inclusion/exclusion may apply.
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Location Details

NCT05579366

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Slightly Honorhealth

Phoenix, Arizona, United States, 85016

RECRUITING

United States, Arizona

USOR Arizona Oncology Associates

Tucson, Arizona, United States, 85711

RECRUITING

United States, California

University of California Los Angeles Medical Center

Los Angeles, California, United States, 90095

RECRUITING

United States, California

University of California, San Diego; Moores Cancer Center

San Diego, California, United States, 92093

RECRUITING

United States, California

Slightly clinical sansum

Santa Barbara, California, United States, 93105

RECRUITING

United States, California

Providence Medical Foundation

Santa Rosa, California, United States, 95403

RECRUITING

United States, Florida

USOR Florida Cancer Specialists South

Fort Myers, Florida, United States, 33908

RECRUITING

United States, Florida

USOR Florida Cancer Specialists North

Saint Petersburg, Florida, United States, 33709

RECRUITING

United States, Florida

USOR Florida Cancer Specialists East

West Palm Beach, Florida, United States, 33401

RECRUITING

United States, Kansas

University of Kansas Medical Center (KUMC)

Westwood, Kansas, United States, 66205

RECRUITING

United States, Maryland

USOR Maryland Oncology Hematology

Rockville, Maryland, United States, 20850

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48085

RECRUITING

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Minnesota

USOR Minnesota Oncology Hematology

Maplewood, Minnesota, United States, 55109

RECRUITING

United States, Oklahola

University of Oklahoma - Health Sciences Center

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Oregon

USOR Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States, 97401

RECRUITING

United States, Oregon

Compass Oncology - Rose Quarter

Portland, Oregon, United States, 97227

RECRUITING

United States, Pennsylvania

USOR Alliance Cancer Specialist

Doylestown, Pennsylvania, United States, 18901

RECRUITING

United States, Rhode Island

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

USOR Texas Oncology

Abilene, Texas, United States, 79606

RECRUITING

United States, Texas

Texas Oncology - Central / South Texas

Austin, Texas, United States, 78758

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75521

RECRUITING

United States, Texas

USOR Texas Oncology

Fort Worth, Texas, United States, 76104

RECRUITING

United States, Texas

Texas Oncology - Northeast TX

Tyler, Texas, United States, 75702

RECRUITING

United States, Texas

USOR Texas Oncology Gulf Coast

Woodland, Texas, United States, 77380

RECRUITING

United States, Utah

START Mountain Region

West Valley City, Utah, United States, 84119

RECRUITING

United States, Virginia

USOR Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Virginia

USOR Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

RECRUITING

China, Beijing

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing, China,

RECRUITING

China, Hunan

Hunan Cancer Hospital - Phase 1

Changsha, Hunan, China,

RECRUITING

China, Hunan

Hunan Cancer Hospital - Thoracic Medicine Dept II

Changsha, Hunan, China,

RECRUITING

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China,

RECRUITING

China, Shanghai

Fudan University Shanghai Cancer Center - Gynecologic Oncology

Shanghai, Shanghai, China,

RECRUITING

China, Shanghai

Fudan University Shanghai Cancer Center- Phase 1

Shanghai, Shanghai, China,