AMT-116 in Combination With Ivosidan in Patients With Lung Cancer (NCT07590531) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
AMT-116 in Combination With Ivosidan in Patients With Lung Cancer
China118 participantsStarted 2026-05-01
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with ivosidan (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.
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
. Willing and able to provide written informed consent for this trial.
. At the time of screening, aged ≥18 years and ≤75 years.
. Histologically or cytologically confirmed locally advanced (Stage IIIB/III C) or metastatic (Stage IV) NSCLC that is not amenable to complete surgical resection and cannot be treated with curative concurrent or sequential chemoradiotherapy (according to the 8th edition of the International Union Against Cancer and the American Joint Committee on Cancer TNM staging for lung cancer).
. Stage Ib: Locally advanced/metastatic NSCLC; both subjects who have previously received systemic therapy and those who have not may be enrolled;
. Subjects must have at least one measurable lesion (as defined by RECIST 1.1 criteria).
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Expected survival of ≥12 weeks.
. Subjects' laboratory test results must meet the requirements.
Exclusion criteria
. Histopathological evidence of small cell lung cancer.
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.
What they're measuring
1
Phase I: To evaluate the safety and tolerability of the combination of AMT-116 and AK112 in patients with advanced NSCLC and to determine the recommended Phase 2 dose (RP2CD)
Timeframe: approximately 10 months
2
Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)
Timeframe: approximately 10 months
3
Phase II: Objective Response Rate(ORR)
Timeframe: approximately 12 months
4
Phase II: Type, incidence and severity of Adverse Events
. For Cohort 1 and Cohort 2 of Phase II, patients must not have non-small cell lung cancer with known EGFR-sensitive mutations, ALK fusions, BRAF V600E mutations, ROS1 fusions, MET exon 14 skipping mutations, NTRK fusions, or RET fusions.
. Prior treatment with any CD44v9-targeted therapy or an antibody-drug conjugate (ADC) based on a topoisomerase I inhibitor as the toxin.
. Received the following treatments or medications prior to the start of the study:
. Received systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to the first dose.
. Adverse reactions from prior treatment have not yet resolved to Grade 1 or less.
. Subjects who have experienced an immune-related adverse event (irAE) requiring permanent discontinuation of treatment, or a Grade 3 or higher irAE, or a cardiac, neurological, or ocular irAE of any grade (including Grade 2 immune-related pneumonia, but excluding Grade 3 hypothyroidism that can be controlled with hormone replacement therapy).
. Known symptomatic brain metastases or other central nervous system (CNS) metastases, or brain metastases or other CNS metastases that the investigator deems to require treatment but have not been treated. Subjects with asymptomatic brain metastases or a history of brain metastases that have been stable for ≥2 weeks prior to the first dose may be eligible for this study, provided they meet all of the following criteria: no metastases to the meninges, midbrain, pons, cerebellum, medulla oblongata, or spinal cord, or spinal cord compression; discontinuation of hormonal therapy for more than 2 weeks prior to the first dose; imaging studies performed within at least 4 weeks show no evidence of new or enlarged brain metastases.