Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mocertatug rezetecan · 5 trials · 4 indications
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first
PFS is defined as the time from the date of randomization to the date of first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
OS is defined as the time from the date of randomization to the date of death due to any cause
ORR is defined as the percentage of participants with best overall confirmed response of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR)
ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
| Arm | Type | Description |
|---|---|---|
| Mocertatug rezetecan +/- Bevacizumab | EXPERIMENTAL | - |
| Active Observation +/- Bevacizumab | ACTIVE_COMPARATOR | - |
| Mocertatug rezetecan (Mo-Rez) + Bevacizumab | EXPERIMENTAL | Participants will receive Mo-Rez + bevacizumab. |
| Platinum doublet + Bevacizumab | ACTIVE_COMPARATOR | Participants will receive platinum doublet chemotherapy (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin \[PLD\]) and bevacizumab, followed by bevacizumab maintenance therapy. |
| Mocertatug rezetecan | EXPERIMENTAL | Participants will receive Mocertatug rezetecan |
| Standard of care | ACTIVE_COMPARATOR | Participants will receive standard of care chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with advanced solid tumors who are refractory or intolerant to established standard therapies |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC) |
| Name | Type | Description |
|---|---|---|
| Mocertatug rezetecan | DRUG | Mocertatug rezetecan will be administered |
| Bevacizumab | DRUG | Bevacizumab will be administered |
| Mocertatug rezetecan (Mo-Rez) | DRUG | Mocertatug rezetecan will be administered |
| Carboplatin | DRUG | Carboplatin will be administered |
| Paclitaxel | DRUG | Paclitaxel will be administered |
| Gemcitabine | DRUG | Gemcitabine will be administered |
| Pegylated liposomal doxorubicin (PLD) | DRUG | PLD will be administered |
| Topotecan | DRUG | Topotecan will be administered |
| Pembrolizumab | DRUG | Pembrolizumab will be administered |
| Doxorubicin | DRUG | Doxorubicin will be administered |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF). * Has new...