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Also known as Rinatabart sesutecan, GEN1184, PRO1184
Rina-S · 9 trials · 23 indications
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.
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Measurement of maximum plasma concentration after the administration of Rina-S.\[
Measurement of AUC after the administration of Rina-S.
| Arm | Type | Description |
|---|---|---|
| Rina-S + SOC | EXPERIMENTAL | Participants will receive Rina-S + SOC. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation). |
| SOC | ACTIVE_COMPARATOR | Participants will receive SOC alone. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation). |
| Arm 1: Rina-S ± Bevacizumab | EXPERIMENTAL | Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W). |
| Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab | ACTIVE_COMPARATOR | Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab. |
| Rina-S | EXPERIMENTAL | - |
| Investigator's Choice | ACTIVE_COMPARATOR | - |
| IC | ACTIVE_COMPARATOR | Participants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W. |
| Part A, B, C, E, F, G, H, I, J and K | EXPERIMENTAL | Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K. |
| Part D1 | EXPERIMENTAL | Rina-S in combination with carboplatin |
| Part D2 and I | EXPERIMENTAL | Rina-S in combination with bevacizumab |
| Part D3, D4 and D5 | EXPERIMENTAL | Rina-S in combination with pembrolizumab |
| Part L | EXPERIMENTAL | Rina-S in combination with CYP3A4 inhibitors erythromycin or itraconazole. |
| Name | Type | Description |
|---|---|---|
| Rina-S | DRUG | Intravenous (IV) infusion. |
| Bevacizumab | DRUG | IV infusion. |
| Carboplatin | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| Paclitaxel | DRUG | IV infusion |
| PLD | DRUG | IV infusion |
| Topotecan | DRUG | IV infusion |
| Pegylated liposomal doxorubicin (PLD) | DRUG | IV infusion |
| IC | DRUG | * Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion |
| Pembrolizumab | DRUG | Pembrolizumab intravenous infusion |
| Erythromycin | DRUG | Erythromycin oral administration |
| Itraconazole | DRUG | Itraconazole oral administration |
Key Inclusion Criteria: * Newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III, or IV high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube carcinoma. * Participants must have rec...
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Rina-S is an investigational small molecule oncology drug being developed by Genmab A/S for the treatment of several solid tumor types. It is in Phase 3 clinical development for ovarian cancer and Phase 2 development for gastrointestinal cancers. Rina-S has not been approved by the FDA and remains under clinical investigation.
Rina-S is being studied for ovarian cancer, including platinum-sensitive and platinum-resistant disease, as well as gastrointestinal cancers, endometrial cancer, high grade epithelial ovarian cancer, and non-small cell lung cancer. Its most advanced programs are in ovarian cancer, where it is in Phase 3 testing.
Rina-S is being developed by Genmab A/S, a biotechnology company listed under the ticker GMAB. Genmab is running the clinical program, which includes Phase 3 trials in ovarian cancer and a Phase 2 trial in gastrointestinal cancers.
Rina-S is in Phase 3 clinical development. Two Phase 3 trials are underway in ovarian cancer, and a Phase 2 trial is recruiting in advanced gastrointestinal cancers. Rina-S is investigational and has not received FDA approval.
Rina-S is being evaluated in four registered trials. These include NCT07859215 in first-line ovarian cancer, NCT07604766 in platinum-resistant ovarian cancer in China, NCT07564141 in recurrent platinum-sensitive ovarian cancer, and NCT07539311 in advanced gastrointestinal cancers. Total planned enrollment across these studies is approximately 1,146 participants.
Yes. Rina-S is being tested in platinum-sensitive ovarian cancer in the Phase 3 trial NCT07564141, which compares Rina-S with or without bevacizumab against investigator's choice of platinum-based chemotherapy with or without bevacizumab as second-line treatment. That trial is recruiting in the United States and Japan.