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A PhaseI/IIFirsHumStuSafeToleraPharmacokine&AntitumActBH30643AdSubW/LocAdvMetNSCL HarbEGFRHER2Muta

UCI Specialty Area: Cancer
Principal Investigator: Misako Nagasaka
Official Title: A Phase I/II Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)
A Study On:
Lung

Study Description

BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.

Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.

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

-Greater or equal to 18 years or legal adult.

-Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.

-Had received standard therapies.

-Has at least 1 measurable target extracranial lesion according to RECIST v1.1.

-Eastern Cooperative Oncology Group Performance Status less or equal to 1.

-Has a life expectancy of greater or equal to 3 months.

-Has adequate hematologic, hepatic, and renal function.

*The above are a summary; other Inclusion Criteria details may apply.

-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.

-History of interstitial lung disease from any cause

-Clinically significant cardiovascular event within 6 months or significant history of major organ.

-Actively receiving investigational therapy(ies) in another clinical study.

*The above are a summary; other Exclusion Criteria details may apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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