Recruiting
Phase 1
Phase 2

Rinatabart Sesutecan

Sponsor:

Genmab

Code:

NCT05579366

Conditions

High Grade Epithelial Ovarian Cancer

High Grade Serous Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rina-S

Carboplatin

Bevacizumab

Pembrolizumab

Study Details

Brief summary:

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

High Grade Epithelial Ovarian Cancer

High Grade Serous Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Endometrial Cancer

Study ID

NCT05579366

Start date

Dec 7, 2022

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

884 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Part D1

Rina-S in combination with carboplatin

experimental: Part D2 and I

Rina-S in combination with bevacizumab

experimental: Part D3 and D4

Rina-S in combination with pembrolizumab

Interventions

Rina-S

Intravenous infusion of Rina-S

Carboplatin

Carboplatin intravenous infusion

Bevacizumab

Bevacizumab intravenous infusion

Pembrolizumab

Pembrolizumab intravenous infusion

Primary outcome measure

  • 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. ]
  • Parts A, and D - Dose Limiting Toxicity (DLT) [ Time Frame: At the end of Cycle 1 (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. ]
  • 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) ]

Central Contacts and Locations

Central contacts

Genmab Trial Information

+4570202728clinicaltrials@genmab.com

Locations

USOR HonorHealth

Recruiting

Phoenix, Arizona, United States, 85016

USOR Arizona Oncology Associates

Recruiting

Tucson, Arizona, United States, 85711

University of California Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90095

University of California, San Diego; Moores Cancer Center

Recruiting

San Diego, California, United States, 92093

USOR Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

USOR Florida Cancer Specialists South

Recruiting

Fort Myers, Florida, United States, 33908

USOR Florida Cancer Specialists North

Recruiting

St. Petersburg, Florida, United States, 33709

USOR Florida Cancer Specialists East

Recruiting

West Palm Beach, Florida, United States, 33401

Augusta University Georgia Cancer Center

Recruiting

Augusta, Georgia, United States, 30912

University of Kansas Medical Center (KUMC)

Recruiting

Westwood, Kansas, United States, 66205

USOR Maryland Oncology Hematology

Recruiting

Rockville, Maryland, United States, 20850

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48085

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49503

USOR Minnesota Oncology Hematology

Recruiting

Maplewood, Minnesota, United States, 55109

MD Anderson Cancer Center at Cooper- Two Cooper Plaza

Recruiting

Camden, New Jersey, United States, 08103

Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

University of Oklahoma - Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

USOR Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

Compass Oncology - Rose Quarter

Recruiting

Portland, Oregon, United States, 97227

USOR Alliance Cancer Specialist

Recruiting

Doylestown, Pennsylvania, United States, 18901

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Women and Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Sarah Cannon Research Institute at Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

USOR Texas Oncology

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology - Central / South Texas

Recruiting

Austin, Texas, United States, 78758

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75521

USOR Texas Oncology

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology - Northeast TX

Recruiting

Tyler, Texas, United States, 75702

USOR Texas Oncology Gulf Coast

Recruiting

Woodland, Texas, United States, 77380

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

USOR Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

USOR Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Genmab

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • antibody-drug conjugate
  • folate receptor alpha
  • folate receptor
  • solid tumor
  • ovarian cancer
  • primary peritoneal carcinoma
  • fallopian tube cancer
  • endometrial cancer
  • non-small cell lung cancer
  • mesothelioma
  • breast cancer
  • triple negative breast cancer
  • hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  • topoisomerase I inhibitor
  • PROC
  • epidermal growth factor receptor (EGFR)-mutated NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genmab on 2026-08-04.