Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.

NCT07742956 | Not Yet Recruiting Phase 2

• 1 other identifier: ALK201-03
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

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%

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

NSCLC; sqNSCLC

Outcome Measures

Primary Outcomes (1)

• TEAEs

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

  Up to 24 months

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  Up to 24 months

• ADAs

  Up to 24 months

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

  up to 24 months

• Objective Response Rate(ORR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

Study Arms (2)

Primary cohort

EXPERIMENTAL

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.

Drug: ALK201 for injection; Drug: Ivonescimab Injection

Exploratory cohort

EXPERIMENTAL

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.

Drug: ALK201 for injection; Drug: Ivonescimab Injection

Interventions

ALK201 for injection DRUG

Subjects will be randomized 1:1 to the two dose levels selected from Part A. The administered dose will be calculated based on the assigned dose arm and the subject's body weight.

Exploratory cohort; Primary cohort

Ivonescimab Injection DRUG

The administered dose will be calculated based on a fixed dose of 20 mg/kg and the subject's body weight.

Exploratory cohort; Primary cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject fully understands and agrees to comply with all study procedures, and voluntarily signs the pre-screening informed consent form and main study informed consent form.
• Aged ≥18 years and ≤75 years at the time of informed consent signature, with no gender restriction.
• Expected overall survival ≥3 months.
• At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with radiotherapy or other local therapies may serve as target lesions if radiological evidence of disease progression in such lesions is confirmed.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Subjects must have adequate organ function, and have not received blood transfusion or hematopoietic growth factor support within 14 days prior to the first administration of ALK201.
• Serum pregnancy test result is negative for female subjects of childbearing potential during the screening period.

You may not qualify if:

• Adverse events related to prior anti-tumor therapy have not recovered to Grade ≤1 per NCI-CTCAE Version 6.0. Exceptions include alopecia, hypothyroidism stabilized with hormone replacement therapy, and Grade 2 toxicities judged by the Investigator to pose no safety risk (Grade 2 neuropathy is excluded).
• Use of strong cytochrome P450 (CYP) 3A4 inhibitors, strong CYP3A4 inducers, or relevant foods within 2 weeks or 5 half-lives prior to the first administration of ALK201 and combination therapy, whichever is longer.
• History of other malignancies besides the study disease within 5 years prior to enrollment, except malignancies cured by radical treatment without evidence of recurrence, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, low-risk prostate cancer, and ductal carcinoma in situ of the breast.
• Presence of clinically symptomatic, poorly controlled, or recurrently drained pleural effusion, pericardial effusion, or ascites.
• Planned major surgery during study treatment, or subjects within the postoperative recovery period following major surgery. Subjects with prior major surgery must fully recover from surgical toxicities and/or complications to Grade ≤1 per CTCAE v6.0 before the first study drug administration; otherwise, they will be excluded.
• Evidence of severe or uncontrolled systemic diseases (e.g., decompensated respiratory, hepatic, or renal disorders).
• History of solid organ transplantation or hematopoietic stem cell transplantation.
• Administration of live attenuated vaccines within 4 weeks before the first dose of ALK201.
• Female subjects who are pregnant or breastfeeding.

Sponsors & Collaborators

• Shanghai Allink Biotherapeutics Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Injections

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

Central Study Contacts

Chaochao Du

CONTACT

+8613122503303; ccdu@allinkbio.com

Xiaofei Tang

CONTACT

+8618502921630; xftang@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: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share