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)

Secondary

• Safety

  Time frame: From enrollment through study completion, approximately 48 months.

• 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.

• Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).

  Time frame: Predose and up to 24 hours postdose.

• Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).

  Time frame: Predose and up to 24 hours postdose.

• 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.

• 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).

• 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 study, whichever occurs first (up to approximately 4 years).

• Clinical benefit Rate (CBR)

  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).

• Time to Tumor Response (TTR)

  Time frame: From first dose to the first occurrence of response, assessed up to the date of first documented progression or death from any cause, whichever occurs first (up to approximately 4 years).

• Duration of Response (DOR)

  Time frame: From first occurrence of response 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).

• Progression-free Survival (PFS)

  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).

• Overall Survival

  Time frame: From enrollment until the date of death from any cause, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).

• ERTC-QLC-C30

  Time frame: From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).

• NSCLC-SAQ

  Time frame: From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).