non-small cell lung cancer(NSCLC)
Conditions
Interventions
Experimental:Phase 1 Dose Escalation and Expansion
-BH-30643 monotherapy for dose escalation
-BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data
-BH-306
Sponsors
Zhang Pingkuan
Eligibility
Sex/Gender
All
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 ==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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Dose-limiting toxicities(DLTs) (Phase 1, Dose Escalation) [Time Frame: Within the first 21 days of the first dose of BH-30643.] Assess dose-limiting toxicities (DLTs) as defined in the study protocol. -Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)[Time Frame: Within 21 days of last participant dosed during Dose Expansion/Optimization.] Determine the RP2D for Phase 2. -Objective Response Rate (ORR) (Phase 2)[Time Frame: Approximately 3 years after the first participant dosed.] Determine ORR as assessed by Blinded Independent Central Review (BICR). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Safety [Time Frame: From enrollment through study completion, approximately 48 months.] Assess incidence and severity of treatment-emergent adverse events(TEAEs), as defined by CTCAE, V5.0(Phase 1 and Phase 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). [Time Frame: Predose and up to 24 hours postdose.] Determine area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration(AUClast) of BH-30643. -Maximum observed plasma concentration Cmax) of BH-30643 for Single dose(Phase 1). [Time Frame: Predose and up to 24 hours postdose.] Determine maximum observed plasma concentration Cmax) of BH-30643. -Time to reach Cmax(Tmax)of BH-30643 for Single dose(Phase 1). [Time Frame: Predose and up to 24 hours postdose.] Determine time to reach Cmax(Tmax)of BH-30643. -Area under the plasma concentration-time curve at steady state (AUCss)of BH-30643 for multiple doses(Phase 1) at steady state. [Time Frame: Predose and up to 24 hours postdose.] Determine area under the plasma concentration-time curve at steady state(AUCss)of BH-30643. -Objective Response Rate(ORR)[Time Frame: From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).] The ORR is defined as a complete response(CR)or partial response(PR) per RECIST v1.1 recorded from first treatment until disease progression or start of new anti-cancer therapy. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. -Disease Control Rate (DCR) [Time Frame: From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the st | — |
Countries
AUSTRALIA, CANADA, HONG KONG, Japan, MALAYSIA, SINGAPORE, SOUTH KOREA, TAIWAN, THAILAND, USA
Contacts
Public Contactcontact Clinical trial
ICON Clinical Research GK
Outcome results
None listed