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.
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
This trial does not accept healthy volunteersQualifiers
≥ 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.
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
Design model
Single group
Treatments tested in this trial
BH-30643
DrugBH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.
BH-30643
DrugBH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: Phase 1 Dose Escalation and ExpansionExperimental treatment 1 intervention
Group B: Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Time frame
Within the first 21 days of the first dose of BH-30643.2
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
Determine the RP2D for Phase 2.
Time frame
Within 21 days of last participant dosed during Dose Expansion/Optimization.3
Objective Response Rate (ORR) (Phase 2)
Determine ORR as assessed by Blinded Independent Central Review (BICR).
Time frame
Approximately 3 years after the first participant dosed.Secondary outcomes
1
Safety
Assess incidence and severity of treatment-emergent adverse events (TEAEs), as defined by CTCAE, V5.0 (Phase 1 and Phase 2).
Time frame
From enrollment through study completion, approximately 48 months.2
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643 for Single dose (Phase 1).
Determine area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643.
Time frame
Predose and up to 24 hours postdose.3
Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).
Determine maximum observed plasma concentration (Cmax) of BH-30643.
Time frame
Predose and up to 24 hours postdose.4
Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).
Determine time to reach Cmax (Tmax) of BH-30643.
Time frame
Predose and up to 24 hours postdose.Sponsors and contacts
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Source ClinicalTrials.gov