Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.
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.
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
TEAEs
Time frame: Up to 12 months
Secondary Endpoints
Peak Plasma Concentration (Cmax)
ADAs
Area under the plasma concentration versus time curve (AUC)
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 1. Previously received EGFR- and/or MET-targeting ADCs and/or ADCs with …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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