RecruitingPhase 1Phase 2NCT05579366

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

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

Sponsor

Genmab

Enrollment

764 participants

Start Date

Dec 7, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Primary Peritoneal Carcinoma Non-small Cell Lung Cancer Breast Adenocarcinoma Fallopian Tube Cancer Mesothelioma High Grade Epithelial Ovarian Cancer High Grade Serous Ovarian Cancer Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called rinatabart sesutecan (Rina-S) in people with advanced solid tumors that cannot be removed by surgery. It targets a protein called folate receptor alpha, which is found on the surface of certain cancer cells, to deliver a toxic payload directly to the tumor. **You may be eligible if...** - You have advanced cancer that has been confirmed by biopsy, including ovarian, endometrial, lung (non-small cell), breast, mesothelioma, or cervical cancer - Your cancer can be measured on scans - You have already received standard treatments for your cancer type - For certain parts of the trial, specific cancer types or genetic mutations may be required **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant - You received cancer treatment (chemo, hormone therapy, or radiation) within the past 3 weeks - Your doctor determines you are too unwell to safely participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRina-S

Intravenous infusion of Rina-S

DRUGCarboplatin

Carboplatin intravenous infusion

DRUGBevacizumab

Bevacizumab intravenous infusion

DRUGPembrolizumab

Pembrolizumab intravenous infusion

Locations(66)

USOR HonorHealth

Phoenix, Arizona, United States

USOR Arizona Oncology Associates

Tucson, Arizona, United States

University of California Los Angeles Medical Center

Los Angeles, California, United States

University of California, San Diego; Moores Cancer Center

San Diego, California, United States

USOR Sansum Clinic

Santa Barbara, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

USOR Florida Cancer Specialists South

Fort Myers, Florida, United States

USOR Florida Cancer Specialists North

St. Petersburg, Florida, United States

USOR Florida Cancer Specialists East

West Palm Beach, Florida, United States

Augusta University Georgia Cancer Center

Augusta, Georgia, United States

University of Kansas Medical Center (KUMC)

Westwood, Kansas, United States

USOR Maryland Oncology Hematology

Rockville, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

USOR Minnesota Oncology Hematology

Maplewood, Minnesota, United States

MD Anderson Cancer Center at Cooper- Two Cooper Plaza

Camden, New Jersey, United States

Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

University of Oklahoma - Health Sciences Center

Oklahoma City, Oklahoma, United States

USOR Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Compass Oncology - Rose Quarter

Portland, Oregon, United States

USOR Alliance Cancer Specialist

Doylestown, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

USOR Texas Oncology

Abilene, Texas, United States

Texas Oncology - Central / South Texas

Austin, Texas, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

USOR Texas Oncology

Fort Worth, Texas, United States

Texas Oncology - Northeast TX

Tyler, Texas, United States

USOR Texas Oncology Gulf Coast

Woodland, Texas, United States

START Mountain Region

West Valley City, Utah, United States

USOR Virginia Cancer Specialists

Fairfax, Virginia, United States

USOR Virginia Oncology Associates

Norfolk, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fujian, China, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangdong, China, China

Second Affiliated Hospital of Zhengzhou University

Henan, China, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, China, China

Second Hospital of Shanxi Medical University

Shanxi, China, China

Shanxi Cancer Hospital

Shanxi, China, China

Liaoning Cancer Hospital & Institute

Shengyang, China, China

Tianjin Cancer Hospital

Tianjin, China, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Hunan Cancer Hospital - Phase 1

Changsha, Hunan, China

Hunan Cancer Hospital - Thoracic Medicine Dept II

Changsha, Hunan, China

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Obstetrics & Gynecology Hospital of Fudan University

Chengdu, Shanghai Municipality, China

Fudan University Shanghai Cancer Center - Gynecologic Oncology

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center- Phase 1

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Shanghai, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Saitama Medical University-International Medical Center

Hidaka, Saitama, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan

Cancer Institute Hospital of JFCR

Koto, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

View Full Details on ClinicalTrials.gov

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