Platinum-resistant Ovarian CancerPhase 3RAINFOL-02NCT07604766
An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China
A Phase 3 study testing Rina-S, Paclitaxel and Topotecan in people with Platinum-resistant Ovarian Cancer, run by Genmab at 17 sites in China.
Trial summary
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Ovarian Cancer
- What is being tested?
- Rina-S, Paclitaxel and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 17 sitesChina
- Study dates
- 26 Jun 2026to Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun
- Recruiting
Hunan Cancer Hospital
Changsha
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu
- Recruiting
Chongqing University Cancer Hospital - Chongqing Cancer Hospital
Chongqing
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
- Recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan
- Recruiting
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Nanjing
- Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai
- Recruiting
Liaoning Cancer Hospital
Shenyang
- Recruiting
Shanxi Cancer Hospital
Taiyuan
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
- Recruiting
Henan Cancer Hospital
Zhengzhou
About this study
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
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
This study is an extension study of the protocol GCT1184-02 (NCT06619236).
- Conditions
- Platinum-resistant Ovarian Cancer
- Being tested
- Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin (PLD), Gemcitabine
- Keywords
- antibody-drug conjugate, folate receptor alpha (FRα), ovarian cancer, fallopian tube cancer, primary peritoneal cancer, folate receptor, platinum-resistant ovarian cancer (PROC), rinatabart sesutecan, Topoisomerase 1 inhibitor, PRO1184, GEN1184
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rina-SDrug
Also called PRO1184, Rinatabart Sesutecan, GEN1184
Intravenous (IV) infusion
PaclitaxelDrug
IV infusion
TopotecanDrug
IV infusion
Pegylated liposomal doxorubicin (PLD)Drug
IV infusion
GemcitabineDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Rina-S | Experimental | Not described Receives: Drug: Rina-S |
| Investigator's Choice | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Measured: Up to approximately 16 months
Secondary outcomes (10)
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause.
Measured: Up to approximately 25 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
Measured: Up to approximately 25 months
PFS as Determined by BICR
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
Measured: Up to approximately 16 months
ORR as Determined by BICR
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Measured: Up to approximately 25 months
Duration of Response (DOR)
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
Measured: Up to approximately 25 months
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
Measured: Up to approximately 25 months
Time to Second Disease Progression or Death From any Cause (PFS2)
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
Measured: Up to approximately 25 months
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.
Measured: Baseline, up to approximately 25 months
Time to Deterioration (TTD) in the GHS/Qol Score
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.
Measured: Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 Jun 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604766
- Sponsor's protocol ID
- GCT1184-02 Extension Study
- Other IDs
- CTR20253987
- Acronym
- RAINFOL-02
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No