Actively Recruiting
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Led by Genmab · Updated on 2026-04-07
764
Participants Needed
66
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Must have histologically or cytologically confirmed metastatic or unresectable solid tumors including specific cancers such as ovarian, endometrial, non-small cell lung, EGFR-mutated NSCLC, breast cancer subtypes, mesothelioma, or cervical cancer.
- Must have measurable disease per RECIST v1.1 or mRECIST v1.1 for mesothelioma.
- Must have received prior therapies known to provide clinical benefit.
- Specific requirements apply for certain cohorts, including prior lines of therapy, platinum sensitivity or resistance, prior bevacizumab, PARP inhibitor treatments, and measurable disease at baseline.
- Participants must continue treatment until disease progression, unacceptable toxicity, or other protocol-stipulated reasons.
You will not qualify if you...
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids within the past 2 years.
- Current interstitial lung disease or pneumonitis.
- Suspected interstitial lung disease or pneumonitis not ruled out by imaging at screening.
- Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
- Other protocol-defined exclusions may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
USOR HonorHealth
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
USOR Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Actively Recruiting
3
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California, San Diego; Moores Cancer Center
San Diego, California, United States, 92093
Actively Recruiting
5
USOR Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
6
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
7
USOR Florida Cancer Specialists South
Fort Myers, Florida, United States, 33908
Actively Recruiting
8
USOR Florida Cancer Specialists North
St. Petersburg, Florida, United States, 33709
Actively Recruiting
9
USOR Florida Cancer Specialists East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
10
Augusta University Georgia Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
11
University of Kansas Medical Center (KUMC)
Westwood, Kansas, United States, 66205
Actively Recruiting
12
USOR Maryland Oncology Hematology
Rockville, Maryland, United States, 20850
Actively Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
Karmanos Cancer Institute
Detroit, Michigan, United States, 48085
Actively Recruiting
16
START Midwest
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
17
USOR Minnesota Oncology Hematology
Maplewood, Minnesota, United States, 55109
Actively Recruiting
18
MD Anderson Cancer Center at Cooper- Two Cooper Plaza
Camden, New Jersey, United States, 08103
Actively Recruiting
19
Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
20
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
21
USOR Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
22
Compass Oncology - Rose Quarter
Portland, Oregon, United States, 97227
Actively Recruiting
23
USOR Alliance Cancer Specialist
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
24
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
25
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
26
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
28
USOR Texas Oncology
Abilene, Texas, United States, 79606
Actively Recruiting
29
Texas Oncology - Central / South Texas
Austin, Texas, United States, 78758
Actively Recruiting
30
Mary Crowley Cancer Research
Dallas, Texas, United States, 75521
Actively Recruiting
31
USOR Texas Oncology
Fort Worth, Texas, United States, 76104
Actively Recruiting
32
Texas Oncology - Northeast TX
Tyler, Texas, United States, 75702
Actively Recruiting
33
USOR Texas Oncology Gulf Coast
Woodland, Texas, United States, 77380
Actively Recruiting
34
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
35
USOR Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
36
USOR Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
37
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
38
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
39
Fujian Cancer Hospital
Fujian, China, China
Actively Recruiting
40
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangdong, China, China
Actively Recruiting
41
Second Affiliated Hospital of Zhengzhou University
Henan, China, China
Actively Recruiting
42
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China, China
Actively Recruiting
43
Second Hospital of Shanxi Medical University
Shanxi, China, China
Actively Recruiting
44
Shanxi Cancer Hospital
Shanxi, China, China
Actively Recruiting
45
Liaoning Cancer Hospital & Institute
Shengyang, China, China
Actively Recruiting
46
Tianjin Cancer Hospital
Tianjin, China, China
Actively Recruiting
47
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
48
Hunan Cancer Hospital - Phase 1
Changsha, Hunan, China
Actively Recruiting
49
Hunan Cancer Hospital - Thoracic Medicine Dept II
Changsha, Hunan, China
Actively Recruiting
50
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Actively Recruiting
51
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
52
Obstetrics & Gynecology Hospital of Fudan University
Chengdu, Shanghai Municipality, China
Actively Recruiting
53
Fudan University Shanghai Cancer Center - Gynecologic Oncology
Shanghai, Shanghai Municipality, China
Actively Recruiting
54
Fudan University Shanghai Cancer Center- Phase 1
Shanghai, Shanghai Municipality, China
Actively Recruiting
55
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
56
Sichuan Cancer Hospital
Shanghai, Sichuan, China
Actively Recruiting
57
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
58
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Actively Recruiting
59
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
Actively Recruiting
60
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
61
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Actively Recruiting
62
Saitama Medical University-International Medical Center
Hidaka, Saitama, Japan
Actively Recruiting
63
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
Actively Recruiting
64
Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Actively Recruiting
65
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Actively Recruiting
66
Yamagata University Hospital
Yamagata, Yamagata, Japan
Actively Recruiting
Research Team
G
Genmab Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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