Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.

Sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
Study ID
NCT07603791
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALK202 for injection — DRUG
    This study employs combined medication. The participants in different groups are treated for non-small cell lung cancer using ALK202 in combination with various drugs.
  • Osimertinib Mesylate Tablets — COMBINATION_PRODUCT
    Combination Drug 1: Osimertinib Mesylate Tablets, ALK202 combine with Osimertinib Mesylate Tablets for cohort1 enrolled participants
  • Ivonescimab Injection — COMBINATION_PRODUCT
    Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection for cohort2 enrolled participants
  • carboplatin injection — COMBINATION_PRODUCT
    Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection and carboplatin injection for cohort3 enrolled participants

Study Details

This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension). Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen. The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets. The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection. The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection. Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety. Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression \< 1% and high c-MET expression that has not received systemic treatment.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort1
    Participants with Non-squamous NSCLC with EGFR mutation that has not received systemic palliative treatment, using the ALK202 combine with the Osimertinib Mesylate Tablets treatment
  • Experimental: cohort2
    Participants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression ≥ 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection treatment
  • Experimental: cohort3
    Participants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression \< 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection and carboplatin injection treatment

Primary Outcome Measure

TEAEs [ Time Frame: Up to 12 months ]

Central Contacts

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