Rina-S
DrugIntravenous (IV) infusion
Other names: PRO1184, Rinatabart Sesutecan, GEN1184
NCT Number: NCT07604766
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).
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 3
Beijing Cancer Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Intravenous (IV) infusion
Other names: PRO1184, Rinatabart Sesutecan, GEN1184
IV infusion
IV infusion
IV infusion
IV infusion
Time frame: Up to approximately 16 months
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.
Time frame: Up to approximately 25 months
OS is defined as the time from date of randomization to date of death due to any cause.
Time frame: Up to approximately 25 months
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.
Time frame: Up to approximately 16 months
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.
Time frame: Up to approximately 25 months
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Time frame: Up to approximately 25 months
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).
Time frame: Up to approximately 25 months
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
Time frame: Up to approximately 25 months
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.
Time frame: Baseline, up to approximately 25 months
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.
Time frame: Up to approximately 25 months
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.
Time frame: Up to approximately 25 months
Contact information is provided by the study sponsor or research team.
Genmab
Industry
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
Acronym: RAINFOL-02
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05281471
Adnexal Diseases, DNA Virus Infections
Mobile, Alabama, United States
View Trial DetailsNCT06619236
Adnexal Diseases, Endocrine Gland Neoplasms
Anchorage, Alaska, United States
View Trial DetailsNCT05198804
Adnexal Diseases, Endocrine Gland Neoplasms
Tucson, Arizona, United States
View Trial DetailsNCT05483933
Adnexal Diseases, Carcinoma
Little Rock, Arkansas, United States
View Trial Details