A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors

NCT07529535 | Suspended Phase 1

• 2 other identifiers: ALK-N001-001CTR20252185
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advance Solid Tumors

Keywords

ALK-N001; Advanced solid tumors; Phase Ia

Outcome Measures

Primary Outcomes (4)

• Dose-Limiting Toxicity（DLT）

  The occurrence of DLT, and determine Maximum Tolerated Dose or Recommended Phase 2 Dose.

  Through study completion, an average of 2 years

• Incidence of Adverse Events (AEs)

  Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of alladverse events (AEs) .

  Through study completion, an average of 2 years

• Incidence of Serious Adverse Events (SAEs)

  Frequency, severity (graded by NCI CTCAE v6.0), and relationship to study drug of serious adverse events (SAEs).

  Through study completion, an average of 2 years

• Incidence of AEs Leading to Permanent Treatment Discontinuation

  Frequency of AEs that result in permanent discontinuation of the study drug.

  Through study completion, an average of 2 years

Secondary Outcomes (12)

• Area Under the Curve (AUC) of ALK-N001

  Through study completion, an average of 2 years

• Maximum Concentration (Cmax) of ALK-N001

  Through study completion, an average of 2 years

• Trough Concentration (Ctrough) of ALK-N001

  Through study completion, an average of 2 years

• Time to Maximum Concentration (Tmax) of ALK-N001

  Through study completion, an average of 2 years

• Clearance (CL) of ALK-N001

  Through study completion, an average of 2 years

Study Arms (6)

ALK-N001（7.5 mg/m2）

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 7.5 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes).

Drug: ALK-N001 for Injection

ALK-N001（15 mg/m2）

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 15 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes).

Drug: ALK-N001 for Injection

ALK-N001（25 mg/m2）

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 25 mg/m², administered by intravenous infusion over a fixed duration of 1 hours (allowable range: ±10 minutes).

Drug: ALK-N001 for Injection

ALK-N001 (37.5 mg/m²)

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 37.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes).

Drug: ALK-N001 for Injection

ALK-N001 (50 mg/m²)

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 50 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes).

Drug: ALK-N001 for Injection

ALK-N001 (62.5 mg/m²)

EXPERIMENTAL

Participants will receive ALK-N001 for Injection at a dose of 62.5 mg/m², administered by intravenous infusion over a fixed duration of 2 hours (allowable range: ±20 minutes).

Drug: ALK-N001 for Injection

Interventions

ALK-N001 for Injection DRUG

The drug is administered via intravenous infusion at a constant rate . The primary dosing schedule was every 2 weeks (Q2W) in a 28-day cycle, while an every 3 weeks (Q3W) schedule with a 21-day cycle was also explored.

Also known as: ALK-N001, QHL-1618

ALK-N001 (37.5 mg/m²); ALK-N001 (50 mg/m²); ALK-N001 (62.5 mg/m²); ALK-N001（15 mg/m2）; ALK-N001（25 mg/m2）; ALK-N001（7.5 mg/m2）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting all of the following criteria may be enrolled in this study:
• Voluntarily sign the informed consent form, understand the study, agree to comply with, and be capable of completing all trial procedures;
• Male or female aged 18 years or older;
• Unresectable and/or metastatic advanced solid tumor confirmed histologically and/or cytologically;
• 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;
• 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:
• \*\*Hematologic system (no blood transfusion or hematopoietic growth factor therapy within 14 days)\*\* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 90 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L \*\*Hepatic function\*\* Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN;
• × ULN for patients with liver metastasis or hepatocellular carcinoma Aspartate aminotransferase (AST) ≤ 3 × ULN;
• × ULN for patients with liver metastasis or hepatocellular carcinoma \*\*Renal function\*\* Creatinine (Cr) ≤ 1.5 × ULN Creatinine clearance (Ccr) (calculated only if Cr \> 1.5 × ULN) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula) \*\*Coagulation function\*\* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
• Males and females of childbearing potential must agree to use non-pharmacological contraceptive measures from signing the informed consent form until 6 months after the last dose of study drug.

You may not qualify if:

• \- Subjects meeting \*\*any\*\* of the following criteria are \*\*ineligible\*\* for enrollment in this study:
• 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\*\*:
• Received anti-cancer endocrine therapy (excluding GnRH agonists or antagonists, endocrine replacement therapy, or contraceptives), oral fluoropyrimidines, small-molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications within \*\*2 weeks or 5 half-lives\*\* (whichever is longer) prior to the first study drug dose;
• Received CAR-T, CAR-NK cell therapy, or tumor vaccine therapy within \*\*3 months\*\* prior to study drug administration;
• Received inactivated viral vaccine within \*\*2 weeks\*\* or non-inactivated viral vaccine within \*\*4 weeks\*\* prior to study drug administration;
• Received other uninvestigational investigational medicinal products within \*\*4 weeks or 5 half-lives\*\* (whichever is shorter) prior to study drug administration.
• 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\*\*.
• Subjects with treated brain metastases may be enrolled if lesions are stable for at least 1 month with no new or enlarging lesions, and steroid therapy has been discontinued for \*\*2 weeks\*\* before the first dose.
• 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:
• Severe cardiac rhythm or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, 2nd-3rd degree atrioventricular block);

Sponsors & Collaborators

• Zhejiang Anglikang Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)