Rina-S extension study in platinum-resistant ovarian cancer in China
Official title: A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer
Run by Genmab · NCT07604766 · Data updated 2026-11-12
This study tests whether Rina-S works as well as standard chemotherapy options for people with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer in China.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 82 (estimated) |
| Sponsor | Genmab Industry-sponsored |
| Drugs / interventions | bevacizumab, Mirvetuximab, chemotherapy |
| Locations | 17 sites (Changchun and 16 other locations) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | September 2027 |
| Study ends | December 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07604766 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who progressed after 1–4 prior therapies and have been treated with platinum chemotherapy and bevacizumab per local guidelines.
✕Probably not a fit
Patients whose tumors do not respond to Rina-S or to standard chemotherapy may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 extension study comparing Rina-S to investigator's choice chemotherapy in Chinese patients with platinum-resistant ovarian cancer. Eligible participants have progressed after 1–4 prior lines of therapy and may have varying levels of FRα expression. All participants receive active treatment, with randomization to Rina-S or one of four approved chemotherapy agents, and treatment assignment remains blinded until the first dose. The study continues the protocol of a preceding trial (GCT1184-02).
Why it matters
Potential benefit: Participants could experience a meaningful improvement in disease control if Rina-S proves superior or equivalent to standard chemotherapy.
How similar studies have gone: Prior studies in related FRα-targeted therapies have shown activity in ovarian cancer, but this extension study evaluates a specific agent (Rina-S) in a China-based, randomized setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. * Participants may be enrolled regardless of FRα expression level. * Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy. * Participants must have received prior treatment with the following therapies: * Platinum chemotherapy * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance * Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations 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 unless the participant is not eligible for treatment with PARP inhibitor * Mirvetuximab soravtansine, if: * Mirvetuximab soravtansine is available in the enrollment region, and * The participant is eligible, and * The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision. * Participants must have platinum-resistant disease: * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum. * Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum. Key Exclusion Criteria: * Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. * Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen. * History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer. * Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. * Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility. * Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Where it's running
-
The First Hospital of Jilin University
Changchun, China Recruiting -
Hunan Cancer Hospital
Changsha, China Recruiting -
West China Second University Hospital, Sichuan University
Chengdu, China Recruiting -
Chongqing University Cancer Hospital - Chongqing Cancer Hospital
Chongqing, China Recruiting -
Sun Yat-Sen Memorial Hospital
Guangzhou, China Recruiting -
Sun Yat-Sen University Cancer Center
Guangzhou, China Recruiting
Show 11 more locations
-
Zhejiang Cancer Hospital
Hangzhou, China Recruiting -
Harbin Medical University Cancer Hospital
Harbin, China Recruiting -
Shandong First Medical University Affiliated Tumor Hospital
Jinan, China Recruiting -
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Nanjing, China Recruiting -
Fudan University Shanghai Cancer Hospital
Shanghai, China Recruiting -
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China Recruiting -
Liaoning Cancer Hospital
Shenyang, China Recruiting -
Shanxi Cancer Hospital
Taiyuan, China Recruiting -
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China Recruiting -
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China Recruiting -
Henan Cancer Hospital
Zhengzhou, China Recruiting
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SYS6043 plus standard chemo vs standard chemo in platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
This study tests SYS6043 against the doctor’s choice chemotherapy in adults with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer to see which treatment works better.
-
OPB-201 therapy for recurrent endometrial and platinum-resistant ovarian cancer
A one-time treatment with a patient’s own T cells engineered to target PRAME is being tested to see if it is safe and what dose works best for adults with recurrent endometrial cancer or platinum-resistant ovarian cancer.
-
GB-5267 for platinum-resistant ovarian, peritoneal, or fallopian tube cancer
This early-phase trial test GB-5267 in adults with platinum-resistant ovarian cancer to see if it is safe and can help shrink tumors.
-
MUC16-targeted antibody-drug HWK-016 for advanced ovarian and endometrial cancer
This will test HWK-016, an antibody-drug that targets MUC16, in adults with advanced or metastatic ovarian or endometrial cancer, including platinum-resistant ovarian cancer.
-
HWK-007, a PTK7-targeted antibody‑drug conjugate for advanced PTK7-positive ovarian, endometrial, and certain non‑squamous lung cancers
This study will try HWK-007, a PTK7-targeted antibody‑drug conjugate given every three weeks, to see if it can shrink or control advanced PTK7-positive ovarian, endometrial, or non-squamous EGFR wild-type lung cancers.
-
MEN2501 treatment for platinum-resistant ovarian cancer
This trial tests a new drug called MEN2501 in adults whose ovarian cancer no longer responds to platinum chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.