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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06784193 | Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 180 | — | — | Dec 16, 2024 | Aug 30, 2027 | Oct 10, 2025 | 8 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| Part 1A Dose Escalation monotherapy | EXPERIMENTAL | - |
| Part 1B Dose Escalation in combination with fulvestrant | EXPERIMENTAL | - |
| Part 1C Dose Escalation in combination with palazestrant | EXPERIMENTAL | - |
| Part 2A Dose Expansion monotherapy - mBC | EXPERIMENTAL | - |
| Part 2A Dose Expansion monotherapy - mCRPC | EXPERIMENTAL | - |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1 | EXPERIMENTAL | - |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OP-3136 | DRUG | Selective inhibitor of HAT enzymes KAT6A and KAT6B |
| Fulvestrant | DRUG | Selective estrogen receptor degrader (SERD) |
| Palazestrant | DRUG | Complete estrogen receptor antagonist (CERAN) |
Key Inclusion Criteria: * Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2). * Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for...