A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors (NCT07529535) | Clinical Trial Compass
SuspendedPhase 1
A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors
Stopped: Participant recruitment has been stopped because the planned sample size has been reached.
China16 participantsStarted 2025-06-05
Plain-language summary
This study is a multicenter, open-label, dose-escalation plus rollover and cohort expansion Phase I/II clinical trial conducted in patients with advanced solid tumors, including esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma.
Who can participate
Age range
18 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
. Voluntarily sign the informed consent form, understand the study, agree to comply with, and be capable of completing all trial procedures;
. Dose escalation + rollover phase (Phase Ia): Patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are intolerant to standard treatment (esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma are prioritized); Cohort expansion phase (Phase Ib/II): Divided into 4 cohorts: ① Esophageal squamous cell carcinoma cohort: Failed at least one line of standard treatment; ② Small cell lung cancer cohort: Failed at least one line of standard treatment; ③ Gastric/gastroesophageal junction adenocarcinoma cohort: Failed at least one line of standard treatment; ④ Other solid tumor cohort (the Sponsor and Investigator will jointly decide whether to initiate Cohort 4 and which indications to enroll based on the safety, pharmacokinetics, and efficacy results of the investigational product). Documented radiologically confirmed disease progression after the last anti-tumor therapy;
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
Dose-Limiting Toxicity（DLT）
Timeframe: Through study completion, an average of 2 years
2
Incidence of Adverse Events (AEs)
Timeframe: Through study completion, an average of 2 years
3
Incidence of Serious Adverse Events (SAEs)
Timeframe: Through study completion, an average of 2 years
4
Incidence of AEs Leading to Permanent Treatment Discontinuation
Timeframe: Through study completion, an average of 2 years
. At least one measurable tumor lesion according to RECIST version 1.1 (lesions in previously irradiated or other locally treated areas are generally not considered measurable unless clear progression is observed);
. ECOG performance status 0-1;
. Life expectancy ≥ 3 months;
. Adequate organ function meeting the following criteria:
Exclusion criteria
. Received chemotherapy, radiotherapy (local bone radiotherapy within 2 weeks), biotherapy, macromolecular targeted therapy, immunotherapy, TIL cell therapy, or other anti-tumor treatments within \*\*4 weeks\*\* prior to the first dose of study drug, \*\*except\*\*:
. Used \*\*strong CYP3A4 inducers or strong inhibitors\*\* within 7 days before the first dose, or requires such agents during the study period.
. Known \*\*severe hypersensitivity\*\* to any component of the investigational product (NCI-CTCAE v5.0 grade ≥ 3).
. Presence of \*\*central nervous system (CNS) metastases and/or leptomeningeal metastases\*\*.
. Diagnosis of \*\*another malignancy within 5 years\*\* prior to enrollment, \*\*except\*\* cured carcinoma in situ of the cervix, squamous cell carcinoma of the skin, basal cell carcinoma, or papillary thyroid carcinoma.
. Clinically \*\*uncontrolled third-space fluid effusion\*\* deemed inappropriate by the investigator.
. History of severe gastrointestinal disorders including chronic inflammatory bowel disease, intestinal obstruction, or chronic diarrhea.
. Severe cardiovascular disease, including but not limited to: