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

May 21, 2026 updated by: Genmab

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

884

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
    • China
      • Fujian, China, China
        • Recruiting
        • Fujian Cancer Hospital
      • Guangdong, China, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Henan, China, China
        • Recruiting
        • Second Affiliated Hospital of Zhengzhou University
      • Hubei, China, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Shanxi, China, China
        • Recruiting
        • Second Hospital of Shanxi Medical University
      • Shanxi, China, China
        • Recruiting
        • Shanxi Cancer Hospital
      • Shengyang, China, China
        • Recruiting
        • Liaoning Cancer Hospital & Institute
      • Tianjin, China, China
        • Recruiting
        • Tianjin Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital - Phase 1
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital - Thoracic Medicine Dept II
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Maternal and Child Health Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Chengdu, Shanghai Municipality, China
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center - Gynecologic Oncology
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center- Phase 1
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai East Hospital
    • Sichuan
      • Shanghai, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
  • Japan
    • Fukushima
      • Fukushima, Fukushima, Japan
        • Recruiting
        • Fukushima Medical University Hospital
    • Gunma
      • Ōta, Gunma, Japan
        • Recruiting
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi, Hyōgo, Japan
        • Recruiting
        • Hyogo Cancer Center
    • Saitama
      • Hidaka, Saitama, Japan
        • Recruiting
        • Saitama Medical University-International Medical Center
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japan
        • Recruiting
        • Shizuoka Cancer Center
    • Tokyo
      • Koto, Tokyo, Japan
        • Recruiting
        • Cancer Institute Hospital of JFCR
      • Shinjuku-ku, Tokyo, Japan
        • Recruiting
        • Keio University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japan
        • Recruiting
        • Yamagata University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • USOR HonorHealth
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • USOR Arizona Oncology Associates
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Medical Center
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego; Moores Cancer Center
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • USOR Sansum Clinic
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • USOR Florida Cancer Specialists South
      • St. Petersburg, Florida, United States, 33709
        • Recruiting
        • USOR Florida Cancer Specialists North
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • USOR Florida Cancer Specialists East
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Georgia Cancer Center
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center (KUMC)
        • Contact:
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • USOR Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48085
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • START Midwest
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • USOR Minnesota Oncology Hematology
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • MD Anderson Cancer Center at Cooper- Two Cooper Plaza
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma - Health Sciences Center
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • USOR Oncology Associates of Oregon, P.C.
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Compass Oncology - Rose Quarter
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Recruiting
        • USOR Alliance Cancer Specialist
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health Network
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute at Tennessee Oncology
        • Contact:
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • USOR Texas Oncology
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central / South Texas
      • Dallas, Texas, United States, 75521
        • Recruiting
        • Mary Crowley Cancer Research
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • USOR Texas Oncology
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Northeast TX
      • Woodland, Texas, United States, 77380
        • Recruiting
        • USOR Texas Oncology Gulf Coast
    • Utah
      • West Valley City, Utah, United States, 84119
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • USOR Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • USOR Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Part A and B:

  • 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, E, 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:

• Endometrial cancer (any subtype excluding sarcoma).

Cohort D4:

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

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:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Note: Other protocol-defined inclusion/exclusion may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part D1
Rina-S in combination with carboplatin
Drug: Rina-S
Intravenous infusion of Rina-S
Other Names:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Drug: Carboplatin
Carboplatin intravenous infusion
Experimental: Part D2 and I
Rina-S in combination with bevacizumab
Drug: Rina-S
Intravenous infusion of Rina-S
Other Names:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Drug: Bevacizumab
Bevacizumab intravenous infusion
Experimental: Part D3 and D4
Rina-S in combination with pembrolizumab
Drug: Rina-S
Intravenous infusion of Rina-S
Other Names:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Drug: Pembrolizumab
Pembrolizumab intravenous infusion
Experimental: Part A, B, C, E, F, G, H, I, J and K
Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
Drug: Rina-S
Intravenous infusion of Rina-S
Other Names:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A, and D - Dose Limiting Toxicity (DLT)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
The proportion of participants experiencing DLT.
At the end of Cycle 1 (each cycle is 21 days)
Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame: Through end of treatment, up to approximately 1 year.
Through end of treatment, up to approximately 1 year.
Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter
Time Frame: Cycles 1 to 3 (each cycle is 21 days)
Cycles 1 to 3 (each cycle is 21 days)
Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Through end of treatment, up to approximately 1 year.
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Through end of treatment, up to approximately 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A, B, and D - Best Overall Response (BOR)
Time Frame: Up to approximately 1 year.
Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.
Up to approximately 1 year.
Parts A, B, and D - Disease Control Rate (DCR)
Time Frame: Up to approximately 1 year.
Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, D, and E - ORR
Time Frame: Up to approximately 1 year.
Participants who achieve PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)
Time Frame: Through end of treatment, up to approximately 1 year.
Time from start of treatment to first documented disease progression or death
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I and J - Overall survival (OS)
Time Frame: Up to approximately 2 years.
Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Parts A, B, C, D, E, F, H, I and J - Duration of Objective Response (DOR)
Time Frame: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Parts A, B, D, and E - Peak Plasma Concentration (Cmax) for Rina-S
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of maximum plasma concentration after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts A, B, D, and E - Area Under the Plasma Concentration Versus Time Curve (AUC) for Rina-S
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of AUC after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts C, E, F, H, I, J, and K - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs)
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part E - Number of Participants With Antidrug Antibodies (ADA)
Time Frame: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A, B, C, and D - Immunogenic potential of PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Assessment of anti-drug antibodies
Through end of treatment, up to approximately 1 year.
Parts A and B - Overall survival
Time Frame: Up to approximately 2 years.
Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Parts A, B, C, and D - Exploratory biomarkers of PRO1184-mediated and disease-related pharmacodynamic effects
Time Frame: Through end of treatment, up to approximately 1 year.
Through end of treatment, up to approximately 1 year.
Part C - Peak Plasma Concentration (Cmax) for PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of maximum plasma concentration after the administration of PRO1184.
Through end of treatment, up to approximately 1 year.
Part C - Area under the plasma concentration versus time curve (AUC) for PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of AUC after the administration of PRO1184.
Through end of treatment, up to approximately 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Study Director: Study Official, Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT1184-01 (Genmab)
  • PRO1184-001 (Other Identifier: Other Sponsor Identifier)
  • CTR20230813 (Registry Identifier: Chinadrugtrials.org.cn)
  • jRCT2051250094 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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