Actively Recruiting
Phase 1/2 Study of Rina-S (GEN1184) for Locally Advanced and Metastatic Solid Tumors Including Ovarian, Endometrial, Lung, Breast Cancer and Mesothelioma
Led by Genmab · Updated on 2026-06-03
884
Participants Needed
66
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Rina-S (also known as GEN1184 or PRO1184), a drug designed to target folate receptor alpha, in people with various advanced solid tumors including ovarian, endometrial, breast, lung cancers, and mesothelioma. This Phase 1/2 study aims to assess the safety, side effects, how the body processes the drug, and its effect on tumors. Participants have tumors that have spread or cannot be removed by surgery and have often received prior treatments. The study includes multiple parts where Rina-S is given alone or combined with other drugs like carboplatin, bevacizumab, or pembrolizumab. Different groups focus on specific tumor types or treatment combinations. Participants receive intravenous infusions of these drugs and continue treatment until the disease worsens, side effects are unacceptable, or other reasons such as withdrawal or pregnancy occur. During the study, participants will undergo regular safety checks, scans to measure tumor response, and blood tests to monitor drug levels and antibodies. Researchers will track side effects, tumor control, survival, and other health measures up to one or two years. The study involves ongoing monitoring through scheduled visits and evaluations to understand the drug's impact and safety over time.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Histologically or cytologically confirmed metastatic or unresectable solid tumors such as epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer, non-small cell lung cancer, EGFR-mutated NSCLC, hormone receptor-positive HER2-negative or triple-negative breast cancer, mesothelioma, or cervical cancer
- Previously received therapies known to provide clinical benefit
- Measurable disease per RECIST v1.1 or mRECIST v1.1 for mesothelioma at baseline
- Specific criteria for ovarian cancer subtypes and prior treatment lines applicable to study parts
- For platinum-resistant ovarian cancer, prior bevacizumab or biosimilar treatment is required
- For certain parts, prior treatment with PD-L1 inhibitors or platinum-based chemotherapy is required
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 exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year or until discontinuation
Participants receive intravenous infusions of Rina-S alone or in combination with carboplatin, bevacizumab, or pembrolizumab depending on their assigned cohort. Treatment continues until disease progression, unacceptable toxicity, or other reasons for discontinuation.
Repeated 21-day cycles with infusions on scheduled days
Duration - Up to approximately 2 years
Participants are monitored after treatment ends for safety, disease progression, and survival for up to approximately 2 years.
Visits scheduled periodically after treatment completion
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
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
40
Hunan Cancer Hospital - Phase 1
Changsha, Hunan, China
Actively Recruiting
41
Hunan Cancer Hospital - Thoracic Medicine Dept II
Changsha, Hunan, China
Actively Recruiting
42
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Actively Recruiting
43
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
44
Obstetrics & Gynecology Hospital of Fudan University
Chengdu, Shanghai Municipality, China
Actively Recruiting
45
Fudan University Shanghai Cancer Center - Gynecologic Oncology
Shanghai, Shanghai Municipality, China
Actively Recruiting
46
Fudan University Shanghai Cancer Center- Phase 1
Shanghai, Shanghai Municipality, China
Actively Recruiting
47
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
48
Sichuan Cancer Hospital
Shanghai, Sichuan, China
Actively Recruiting
49
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
50
Fujian Cancer Hospital
Fujian, China
Actively Recruiting
51
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangdong, China
Actively Recruiting
52
Second Affiliated Hospital of Zhengzhou University
Henan, China
Actively Recruiting
53
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
Actively Recruiting
54
Second Hospital of Shanxi Medical University
Shanxi, China
Actively Recruiting
55
Shanxi Cancer Hospital
Shanxi, China
Actively Recruiting
56
Liaoning Cancer Hospital & Institute
Shengyang, China
Actively Recruiting
57
Tianjin Cancer Hospital
Tianjin, 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
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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