This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).
Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.
Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:
Primary cohort: PD-L1 expression ≥1% Exploratory cohort: PD-L1 expression <1%
Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) with PD-L1 expression ≥1% will be treated with ALK201 for Injection combined with Ivonescimab Injection, or Ivonescimab Injection monotherapy. Two doses of ALK201 selected from Part A will be applied in the combination arms, with subjects randomized 1:1 between the two ALK201 combination dose groups.
Subjects with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) and PD-L1 expression \<1% will receive ALK201 for Injection in combination with Ivonescimab Injection. Two recommended doses of ALK201 identified in Part A will be used, and subjects will be randomized 1:1 between the two combination dose arms.
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Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.
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