A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Condition(s) studied

Investigational drug(s) / intervention(s)

BH-30643: 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: 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

BH-30643: BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment

Study summary

This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.

Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy.

Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.

Eligibility

Primary outcome measure(s)

• Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) — Within the first 21 days of the first dose of BH-30643.
  Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
• Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization) — Within 21 days of last participant dosed during Dose Expansion/Optimization.
  Determine the RP2D for Phase 2.
• Objective Response Rate (ORR) (Phase 2) — Approximately 3 years after the first participant dosed.
  Determine ORR as assessed by Blinded Independent Central Review (BICR).

Trial sites (42)

+ 2 more sites — see the full list on the official registry below.