Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofe-M · 1 trial · 7 indications
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with DLTs
Number of participants with DLTs
Number of participants with DLTs
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
ORR per RECIST 1.1
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Sofe-M (Dose-escalation, Cohort A1) | EXPERIMENTAL | Escalating doses of Sofe-M administered intravenously (IV) |
| Sofe-M (Cohort A1 Parts A and C) | EXPERIMENTAL | Sofe-M administered IV |
| Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) | EXPERIMENTAL | Sofe-M administered IV and itraconazole administered orally |
| Sofe-M (Dose-optimization, Cohort A2) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV |
| Sofe-M (Enrichment Cohort A3) | EXPERIMENTAL | Monotherapy administered IV |
| Sofe-M (Combination Cohort A4) | EXPERIMENTAL | Combination with bevacizumab administered IV |
| Sofe-M (Combination Cohort A5) | EXPERIMENTAL | Combination with carboplatin administered IV |
| Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab |
| Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab |
| Sofe-M (Dose-expansion, Cohort B2-B4) | EXPERIMENTAL | Sofe-M administered IV |
| Sofe-M (Dose-expansion, Cohort B1) | EXPERIMENTAL | Sofe-M administered IV |
| Name | Type | Description |
|---|---|---|
| Sofe-M | DRUG | Intravenous |
| bevacizumab | DRUG | IV |
| carboplatin | DRUG | IV |
| Itraconazole | DRUG | oral |
| pembrolizumab | DRUG | IV |
Inclusion Criteria: * Have one of the following solid tumor cancers: * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, o...