Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BH-30643 · 1 trial · 1 indication
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Determine the RP2D for Phase 2.
Determine ORR as assessed by Blinded Independent Central Review (BICR).
| Arm | Type | Description |
|---|---|---|
| Phase 1 Monotherapy Dose Escalation and Expansion | EXPERIMENTAL | * BH-30643 monotherapy for dose escalation * BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data |
| Phase 1 Combination Dose Escalation and Expansion | EXPERIMENTAL | * BH-30643 combo therapy with Carboplatin/Pemetrexed for dose escalation * BH-30643 combo therapy with Carboplatin/Pemetrexed for dose expansion /optimization at doses determined from dose escalation data |
| Phase 2 | EXPERIMENTAL | BH-30643 administered at the RP2D dose determined in Phase 1 |
| Name | Type | Description |
|---|---|---|
| BH-30643 | DRUG | BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets. Subjects will take BH-30643 orally depending on their dose level assignment. |
| BH-30643 combo therapy with Carboplatin/Pemetrexed | DRUG | BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets in combo therapy with Carboplatin/Pemetrexed. Subjects will take BH-30643 orally depending on their dose level assignment. Carboplatin/Pemetrexed will be administered according to standard of care |
Inclusion Criteria: * ≥ 18 years or legal adult. * Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. * Has at least 1 measurable target extracranial lesion according to RECIST v1.1. * Eastern Coope...