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

Recruiting Phase 1 Phase 2 Interventional Study
NSCLC (Advanced Non-small Cell Lung Cancer)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
675 (estimated)
Sponsor
BlossomHill Therapeutics · Industry
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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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Sponsor Contact

(858) 732-3880

clinicaltrials@bhtherapeutics.com

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