Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Acti… (NCT07742956) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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.
156 participantsStarted 2026-08-20
Plain-language 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%
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Serum pregnancy test result is negative for female subjects of childbearing potential during the screening period.
Exclusion criteria
. 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.