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

NCT07603791
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Phase
Phase 2
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Recruitment status
Not yet recruiting
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Participants
252
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Lead sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
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Start date
2026-06-30
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Summary
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.
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Short title
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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Official title
An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-12-30
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First posted
2026-05-22
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Registry last updated
2026-05-22
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Primary completion date
2027-12-30
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Start date
2026-06-30
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Participants
252
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Participant count basis
Estimated
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Planned participants
252
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Protocol amendments
0
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Randomisation ratio
1:1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07603791
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ClinicalTrials.gov ID
NCT07603791
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. TEAEs

    Timeframe: Up to 12 months

    Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0

  1. Peak Plasma Concentration (Cmax)

    Timeframe: Up to 12 months

    PK parameters after single andmultiple doses

  2. ADAs

    Timeframe: Up to 12 months

    The generation of anti-drug antibodies

  3. Area under the plasma concentration versus time curve (AUC)

    Timeframe: up to 12 months

    PK parameters after single andmultiple doses

  4. Objective Response Rate(ORR)

    Timeframe: Up to 12 months

    Objective Response Rate(ORR) calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria

  5. Disease Control Rate (DCR)

    Timeframe: Up to 12 months

    DCR calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria

  6. Progression-FreeSurvival (PFS)

    Timeframe: Up to 12 months

    PFS calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. The trial Participants themselves (and/or guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;
  2. Men and women ≥18 and ≤75 years old on the day of signing the ICF;
  3. The trial participants agree to provide fresh or archived tumor tissues for the detection of the expression status of driving genes or proteins (such as EGFR expression, c-MET expression, and PD-L1 expression status, etc.). If the trial participants are unable to provide the required tumor tissues for testing, their participation in the trial must be approved by the sponsor;
  4. The presence of at least one measurable lesion is required according to the RECIST v1.1 criteria. A neoplastic lesion that has received local treatment, such as radiotherapy, can be taken as a target lesion if disease progression is proved by imaging;
  5. Expected survival ≥ 3 months;

  1. Previously received EGFR- and/or MET-targeting ADCs and/or ADCs with topoisomerase I inhibitor as the payload;
  2. Participated in other interventional clinical trials within 4 weeks or 5 drug half-lives before the first dose of ALK202 (whichever is shorter). Note: Patients who have participated in another interventional clinical trial, even if they are still in the survival follow-up period of the previous trial, may be enrolled in this study provided that the first dose of ALK202 is to be administered ≥5 half-lives or 4 weeks from the last dose of the trial drug (whichever is shorter);
  3. Received chemotherapy, targeted therapy, immunotherapy, interventional procedure, or other systemic antitumor therapy within 4 weeks (Note: 6 weeks for nitrosourea or mitomycin C, 2 weeks or 5 half-lives of the drugs [whichever is shorter] for oral fluorouracil and small-molecule targeted drugs, and 2 weeks for Chinese medicines with anti-tumor indications) prior to the first dose of ALK202;
  4. Received radical radiotherapy, whole-brain radiotherapy, or bone marrow irradiation > 30% within 4 weeks before the first dose of ALK202; or palliative radiation (including stereotactic radiotherapy) of non-target lesions for symptom relief purposes within 2 weeks prior to the first dose;
  5. Took drugs or food that strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4 within 2 weeks or within 5 half-lives prior to the first dose of ALK202, whichever is longer.
Sources for eligibility
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Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (2)