A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBlossomHill Therapeutics
About this trial
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 criteria
Qualifiers
≥ 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 Cooperative Oncology Group Performance Status ≤ 1.
Disqualifiers
History of any concurrent malignancy within the previous 2 years.
Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
Unresolved toxicities from prior therapies.
Any significant and uncontrolled medical condition, such as infection.
Trial design
Treatments tested in this trial
- BH-30643
- BH-30643 combo therapy with Carboplatin/Pemetrexed
- BH-30643
Treatment groups
675 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov