Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05579366

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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