Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Start Date
12/7/2022
Completion Date
10/1/2027
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).
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) monotherapy cohort Part D: combination therapy cohorts Part E: a monotherapy PROC cohort Parts F and G: a monotherapy endometrial cancer (EC) cohort Part H: a monotherapy PROC cohort Part I: platinum-sensitive ovarian cancer (PSOC) cohort Part J: a monotherapy PROC cohort Part K: a monotherapy high-grade ovarian 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rina-S
Carboplatin
Bevacizumab
Pembrolizumab
Conditions
Locations
USOR HonorHealth
Phoenix, Arizona 85016
United States
USOR Arizona Oncology Associates
Tucson, Arizona 85711
United States
University of California Los Angeles Medical Center
Los Angeles, California 90095
United States
University of California, San Diego; Moores Cancer Center
San Diego, California 92093
United States
USOR Sansum Clinic
Santa Barbara, California 93105
United States
Providence Medical Foundation
Santa Rosa, California 95403
United States
USOR Florida Cancer Specialists South
Fort Myers, Florida 33908
United States
USOR Florida Cancer Specialists North
St. Petersburg, Florida 33709
United States
USOR Florida Cancer Specialists East
West Palm Beach, Florida 33401
United States
Augusta University Georgia Cancer Center
Augusta, Georgia 30912
United States
University of Kansas Medical Center (KUMC)
Westwood, Kansas 66205
United States
USOR Maryland Oncology Hematology
Rockville, Maryland 20850
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Karmanos Cancer Institute
Detroit, Michigan 48085
United States
START Midwest
Grand Rapids, Michigan 49503
United States
USOR Minnesota Oncology Hematology
Maplewood, Minnesota 55109
United States
MD Anderson Cancer Center at Cooper- Two Cooper Plaza
Camden, New Jersey 08103
United States
Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210
United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
USOR Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401
United States
Compass Oncology - Rose Quarter
Portland, Oregon 97227
United States
USOR Alliance Cancer Specialist
Doylestown, Pennsylvania 18901
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island 02905
United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee 37203
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
USOR Texas Oncology
Abilene, Texas 79606
United States
Texas Oncology - Central / South Texas
Austin, Texas 78758
United States
Mary Crowley Cancer Research
Dallas, Texas 75521
United States
USOR Texas Oncology
Fort Worth, Texas 76104
United States
Texas Oncology - Northeast TX
Tyler, Texas 75702
United States
USOR Texas Oncology Gulf Coast
Woodland, Texas 77380
United States
START Mountain Region
West Valley City, Utah 84119
United States
USOR Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
USOR Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
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
Fujian Cancer Hospital
Fujian,
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangdong,
China
Second Affiliated Hospital of Zhengzhou University
Henan,
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei,
China
Second Hospital of Shanxi Medical University
Shanxi,
China
Shanxi Cancer Hospital
Shanxi,
China
Liaoning Cancer Hospital & Institute
Shengyang,
China
Tianjin Cancer Hospital
Tianjin,
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