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 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ALK202-02
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• TEAEs

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

  Up to 12 months

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  Up to 12 months

• ADAs

  Up to 12 months

• Area under the plasma concentration versus time curve (AUC)

  up to 12 months

• Objective Response Rate(ORR)

  Up to 12 months

• Disease Control Rate (DCR)

  Up to 12 months

Study Arms (3)

cohort1

EXPERIMENTAL

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

Drug: ALK202 for injection; Combination Product: Osimertinib Mesylate Tablets

cohort2

EXPERIMENTAL

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

Drug: ALK202 for injection; Combination Product: Ivonescimab Injection

cohort3

EXPERIMENTAL

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

Drug: ALK202 for injection; Combination Product: Ivonescimab Injection; Combination Product: carboplatin injection

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.

cohort1; cohort2; cohort3

Osimertinib Mesylate Tablets COMBINATION_PRODUCT

Combination Drug 1: Osimertinib Mesylate Tablets, ALK202 combine with Osimertinib Mesylate Tablets for cohort1 enrolled participants

cohort1

Ivonescimab Injection COMBINATION_PRODUCT

Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection for cohort2 enrolled participants

cohort2; cohort3

carboplatin injection COMBINATION_PRODUCT

Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection and carboplatin injection for cohort3 enrolled participants

cohort3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The trial Participants themselves (and/or guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;
• Men and women ≥18 and ≤75 years old on the day of signing the ICF;
• 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;
• 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;
• Expected survival ≥ 3 months;

You may not qualify if:

• Previously received EGFR- and/or MET-targeting ADCs and/or ADCs with topoisomerase I inhibitor as the payload;
• 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);
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Shanghai Allink Biotherapeutics Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Injections; osimertinib; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Coordination Complexes; Organic Chemicals

Central Study Contacts

Mei Tian, Master

CONTACT

+8615800960592; mtian@allinkbio.com

Shuntong Duan, Master

CONTACT

+8619921555831; stduan@allinkbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share