New drug Rina-S shows promise in battling Hard-to-Treat cancers

NCT ID NCT05579366

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This study tests a new drug, Rina-S, in people with advanced solid tumors that have spread or can't be removed by surgery. The goal is to see if Rina-S is safe and how well it works against cancers like ovarian, lung, and breast cancer. About 884 participants will receive the drug, and researchers will monitor side effects and tumor shrinkage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 884 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast adenocarcinoma breast neoplasm endometrial cancer endometrium neoplasm fallopian tube cancer fallopian tube neoplasm mesothelioma non-small cell lung carcinoma ovarian cancer ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma triple-negative breast carcinoma uterine cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast adenocarcinoma Endometrial cancer Epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) Fallopian tube cancer High grade epithelial ovarian cancer High grade serous ovarian cancer Hormone receptor-positive/HER2 negative breast cancer Mesothelioma Non-small cell lung cancer Platinum sensitive ovarian cancer (PSOC) Platinum-resistant ovarian cancer (PROC) Primary peritoneal carcinoma Primary refractory ovarian cancer Triple negative breast cancer Uterine cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

66 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Allegheny Health Network
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Augusta University Georgia Cancer Center
RECRUITING

Augusta, Georgia, 30912, United States
Cancer Institute Hospital of JFCR
RECRUITING

Koto, Tokyo, Japan
Cancer hospital, Chinese Academy of Medical Sciences
RECRUITING

Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
RECRUITING

Chongqing, Chongqing Municipality, China
Compass Oncology - Rose Quarter
RECRUITING

Portland, Oregon, 97227, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Fudan University Shanghai Cancer Center - Gynecologic Oncology
RECRUITING

Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center- Phase 1
RECRUITING

Shanghai, Shanghai Municipality, China
Fujian Cancer Hospital
RECRUITING

Fujian, China
Fukushima Medical University Hospital
RECRUITING

Fukushima, Fukushima, Japan
Gunma Prefectural Cancer Center
RECRUITING

Ōta, Gunma, Japan
Hunan Cancer Hospital - Phase 1
RECRUITING

Changsha, Hunan, China
Hunan Cancer Hospital - Thoracic Medicine Dept II
RECRUITING

Changsha, Hunan, China
Hyogo Cancer Center
RECRUITING

Akashi, Hyōgo, Japan
Jiangxi Maternal and Child Health Hospital
RECRUITING

Nanchang, Jiangxi, China
Jilin Cancer Hospital
RECRUITING

Changchun, Jilin, China
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48085, United States
Keio University Hospital
RECRUITING

Shinjuku-ku, Tokyo, Japan
Liaoning Cancer Hospital & Institute
RECRUITING

Shengyang, China
MD Anderson Cancer Center at Cooper- Two Cooper Plaza
RECRUITING

Camden, New Jersey, 08103, United States
Mary Crowley Cancer Research
RECRUITING

Dallas, Texas, 75521, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Obstetrics & Gynecology Hospital of Fudan University
RECRUITING

Chengdu, Shanghai Municipality, China
Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
RECRUITING

Columbus, Ohio, 43210, United States
Providence Medical Foundation
RECRUITING

Santa Rosa, California, 95403, United States
START Midwest
RECRUITING

Grand Rapids, Michigan, 49503, United States
START Mountain Region
RECRUITING

West Valley City, Utah, 84119, United States
Saitama Medical University-International Medical Center
RECRUITING

Hidaka, Saitama, Japan
Sapporo Medical University Hospital
RECRUITING

Sapporo, Hokkaido, Japan
Sarah Cannon Research Institute at Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
Second Affiliated Hospital of Zhengzhou University
RECRUITING

Henan, China
Second Hospital of Shanxi Medical University
RECRUITING

Shanxi, China
Shanghai East Hospital
RECRUITING

Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
RECRUITING

Shanxi, China
Shizuoka Cancer Center
RECRUITING

Nagaizumi-chō, Shizuoka, Japan
Sichuan Cancer Hospital
RECRUITING

Shanghai, Sichuan, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING

Guangdong, China
Swedish Cancer Institute
RECRUITING

Seattle, Washington, 98104, United States
Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
Texas Oncology - Central / South Texas
RECRUITING

Austin, Texas, 78758, United States
Texas Oncology - Northeast TX
RECRUITING

Tyler, Texas, 75702, United States
Tianjin Cancer Hospital
RECRUITING

Tianjin, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING

Hubei, China
USOR Alliance Cancer Specialist
RECRUITING

Doylestown, Pennsylvania, 18901, United States
USOR Arizona Oncology Associates
RECRUITING

Tucson, Arizona, 85711, United States
USOR Florida Cancer Specialists East
RECRUITING

West Palm Beach, Florida, 33401, United States
USOR Florida Cancer Specialists North
RECRUITING

St. Petersburg, Florida, 33709, United States
USOR Florida Cancer Specialists South
RECRUITING

Fort Myers, Florida, 33908, United States
USOR HonorHealth
RECRUITING

Phoenix, Arizona, 85016, United States
USOR Maryland Oncology Hematology
RECRUITING

Rockville, Maryland, 20850, United States
USOR Minnesota Oncology Hematology
RECRUITING

Maplewood, Minnesota, 55109, United States
USOR Oncology Associates of Oregon, P.C.
RECRUITING

Eugene, Oregon, 97401, United States
USOR Sansum Clinic
RECRUITING

Santa Barbara, California, 93105, United States
USOR Texas Oncology
RECRUITING

Abilene, Texas, 79606, United States
USOR Texas Oncology
RECRUITING

Fort Worth, Texas, 76104, United States
USOR Texas Oncology Gulf Coast
RECRUITING

Woodland, Texas, 77380, United States
USOR Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
USOR Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
University of California Los Angeles Medical Center
RECRUITING

Los Angeles, California, 90095, United States
University of California, San Diego; Moores Cancer Center
RECRUITING

San Diego, California, 92093, United States
University of Kansas Medical Center (KUMC)
RECRUITING

Westwood, Kansas, 66205, United States
University of Oklahoma - Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Women and Infants Hospital of Rhode Island
RECRUITING

Providence, Rhode Island, 02905, United States
Yamagata University Hospital
RECRUITING

Yamagata, Yamagata, Japan
Zhejiang Cancer Hospital
RECRUITING

Hangzhou, Zhejiang, China

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