Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
NCT ID: NCT05579366
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
764 participants
INTERVENTIONAL
2022-12-07
2027-10-31
Brief Summary
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Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
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Detailed Description
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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
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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A, B, C, F, G, H, I, J and K
Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, F, G, H, I, J and K.
Rina-S
Intravenous infusion of Rina-S
Part D1
Rina-S in combination with carboplatin
Rina-S
Intravenous infusion of Rina-S
Carboplatin
Carboplatin intravenous infusion
Part D2 and I
Rina-S in combination with bevacizumab
Rina-S
Intravenous infusion of Rina-S
Bevacizumab
Bevacizumab intravenous infusion
Part D3 and D4
Rina-S in combination with pembrolizumab
Rina-S
Intravenous infusion of Rina-S
Pembrolizumab
Pembrolizumab intravenous infusion
Interventions
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Rina-S
Intravenous infusion of Rina-S
Carboplatin
Carboplatin intravenous infusion
Bevacizumab
Bevacizumab intravenous infusion
Pembrolizumab
Pembrolizumab intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 and D4:
• Endometrial cancer (any subtype excluding sarcoma).
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.
Exclusion Criteria
* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
Note: Other protocol-defined inclusion/exclusion may apply.
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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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
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
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
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
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
National Cancer Center Hospital
Tokyo, , Japan
Countries
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Central Contacts
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Other Identifiers
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CTR20230813
Identifier Type: REGISTRY
Identifier Source: secondary_id
PRO1184-001
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2051250094
Identifier Type: REGISTRY
Identifier Source: secondary_id
GCT1184-01
Identifier Type: -
Identifier Source: org_study_id
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