Clinical Trial 23580

• Overview

  Study Title:

  A Phase 1/2 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)

  Summary:

  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.

  Objective:

  Primary Objectives, Phase 1, Part 1 (Dose Escalation): * To evaluate the safety and tolerability of BH-30643 at increasing dose levels in adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations. * To determine the dose-limiting toxicities (DLTs) of BH-30643 in adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations and the maximum tolerated dose (MTD), if applicable. * To identify the recommended doses for expansion (RDEs). Primary Objectives, Phase 1, Part 2 (Dose Expansion): * To evaluate the safety, tolerability, and preliminary antitumor activity of BH-30643 at selected RDEs to determine the recommended Phase 2 dose (RP2D). Primary Objectives, Phase 2: * To determine the antitumor activity of BH-30643 by response rate in selected populations of adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations at the RP2D. Secondary Objectives, Phase 1: * To characterize the single- and multiple-dose pharmacokinetic (PK) properties of BH-30643. * To characterize the preliminary antitumor activity of BH-30643 in adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations. Secondary Objectives, Phase 2 * To further characterize the antitumor activity of BH-30643 at the RP2D. * To confirm the safety and tolerability of BH-30643 at the RP2D. * To assess the population PK (PopPK) of BH-30643 and to explore correlations between PK, response, and/or safety findings in subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations. * To estimate the effect of BH-30643 on patient reported outcomes (PROs): global health status/Quality of Life (QoL) using the European Organization for Research and Treatment QoL Questionnaire (EORTC-QLQ-C30), and the NSCLC-Symptom Assessment Questionnaire (NSCLC-SAQ).

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor

  Medications:

  BH-30643 ()

• Inclusion Criteria

  Inclusion Criteria:
  • ≥ 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 ≤ 1.
  • Has a life expectancy of ≥ 3 months.
  • Has adequate hematologic, hepatic, and renal function. *The above are a summary; other Inclusion Criteria details may apply.

• Exclusion Criteria

  Exclusion Criteria:
  • 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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