Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rina-S · 8 trials · 22 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.
The proportion of participants experiencing DLT.
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| 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 | - |
| Rina-S + SOC | EXPERIMENTAL | Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation). |
| SOC | ACTIVE_COMPARATOR | Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation). |
| 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 and D4 | EXPERIMENTAL | Rina-S in combination with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Rina-S | BIOLOGICAL | 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 |
Key Inclusion Criteria: * Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer. * Participant must have documented recurrence or progression after first-line (1L) platinum-based chemot...