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 range18 Years
SexALL
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Inclusion criteria
β. Voluntarily sign the informed consent form, understand the study, agree to comply with, and be capable of completing all trial procedures;
β. 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: β Esophageal squamous cell carcinoma cohort: Failed at least one line of standard treatment; β‘ Small cell lung cancer cohort: Failed at least one line of standard treatment; β’ Gastric/gastroesophageal junction adenocarcinoma cohort: Failed at least one line of standard treatment; β£ 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;
β. 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);
β
What they're measuring
1
Dose-Limiting ToxicityοΌDLTοΌ
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
β. Adequate organ function meeting the following criteria:
Exclusion criteria
β. 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\*\*:
β. Used \*\*strong CYP3A4 inducers or strong inhibitors\*\* within 7 days before the first dose, or requires such agents during the study period.
β. Known \*\*severe hypersensitivity\*\* to any component of the investigational product (NCI-CTCAE v5.0 grade β₯ 3).
β. Presence of \*\*central nervous system (CNS) metastases and/or leptomeningeal metastases\*\*.
β. 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.
β. Clinically \*\*uncontrolled third-space fluid effusion\*\* deemed inappropriate by the investigator.
β. History of severe gastrointestinal disorders including chronic inflammatory bowel disease, intestinal obstruction, or chronic diarrhea.
β. Severe cardiovascular disease, including but not limited to: