Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05768139 | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 880 | — | — | Apr 17, 2023 | Jul 1, 2030 | Jun 4, 2026 | 65 | United States, Belgium +7 |
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Advanced Solid Tumors) | EXPERIMENTAL | * Cohort A0: Advanced Solid tumors expressing PI3Kα mutations * Cohort A1: HR+ breast cancer expressing PI3Kα mutations |
| Dose Expansion | EXPERIMENTAL | * Cohort A2: Gynecologic cancers * Cohort A3: Head and Neck Squamous Cell Carcinoma * Cohorts A4/A5: Other solid tumors not included in Cohorts A1, A2, A3 expressing PI3Kα mutations * Cohort A6: Endometrial cancer * Cohort A7: Non-gastrointestinal solid tumors |
| Dose Selection/Expansion: Combination STX-478 + fulvestrant | EXPERIMENTAL | Cohort B: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Kα mutations |
| Dose Selection/Expansion Combination | EXPERIMENTAL | STX-478 + Endocrine therapy + CDK4/6 inhibitor Cohort C/D/E: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Ka mutations |
| Experimental: Drug to Drug Interaction (DDI) Metformin STX-478 +/- ET ([AIs or fulvestrant] | EXPERIMENTAL | CDK4/6 inhibitor therapy in Cohort A8: all solid tumors Cohort B2 and Cohort F: HR+/HER2- or HR+/HER2 low breast cancer expressing PI3Kα mutations |
| Name | Type | Description |
|---|---|---|
| STX-478 | DRUG | STX-478 is a mutant-selective PI3Kα inhibitor |
| Fulvestrant | DRUG | Fulvestrant |
| Ribociclib | DRUG | Ribociclib |
| Palbociclib | DRUG | Palbociclib |
| Letrozole | DRUG | Letrozole |
| Anastrozole | DRUG | Anastrozole |
| Exemestane | DRUG | Exemestane |
| Tamoxifen | DRUG | Tamoxifen |
| Abemaciclib | DRUG | Abemaciclib |
| Imlunestrant | DRUG | Imlunestrant |
| Metformin | DRUG | Metformin |
Key Inclusion Criteria: * Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort) * Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening * Has...