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.

An Open-label, Multicenter Phase II Clinical Trial to Evaluate ALK201 for Injection Combined With Ivonescimab Injection in Subjects With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

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%

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
• Intervention / Treatment: Drug: ALK201 for injection; Drug: Ivonescimab Injection

Detailed Description

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%

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaofei Tang; Phone Number: +8618502921630; Email: xftang@allinkbio.com
• Study Contact Backup: Name: Chaochao Du; Phone Number: +8613122503303; Email: ccdu@allinkbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Aged ≥18 years and ≤75 years at the time of informed consent signature, with no gender restriction.
3. Expected overall survival ≥3 months.
4. 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.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
6. 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.
7. Serum pregnancy test result is negative for female subjects of childbearing potential during the screening period.

Exclusion Criteria:

1. 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).
2. 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.
3. 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.
4. Presence of clinically symptomatic, poorly controlled, or recurrently drained pleural effusion, pericardial effusion, or ascites.
5. 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.
6. Evidence of severe or uncontrolled systemic diseases (e.g., decompensated respiratory, hepatic, or renal disorders).
7. History of solid organ transplantation or hematopoietic stem cell transplantation.
8. Administration of live attenuated vaccines within 4 weeks before the first dose of ALK201.
9. Female subjects who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary cohort; 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; 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.; Drug: Ivonescimab Injection; The administered dose will be calculated based on a fixed dose of 20 mg/kg and the subject's body weight.
Experimental: Exploratory cohort; 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; 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.; Drug: Ivonescimab Injection; The administered dose will be calculated based on a fixed dose of 20 mg/kg and the subject's body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs	Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	PK parameters after single andmultiple doses	Up to 24 months
ADAs	The generation of anti-drug antibodies	Up to 24 months
Area under the plasma concentration versus time curve (AUC)	PK parameters after single andmultiple doses	up to 24 months
Objective Response Rate(ORR)	Objective Response Rate(ORR) calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria	Up to 24 months
Disease Control Rate (DCR)	DCR calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria	Up to 24 months
Progression-FreeSurvival (PFS)	PFS calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria	Up to 24 months

Collaborators and Investigators

• Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; sqNSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: ALK201-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No