RecruitingInterventionalPhase 1/Phase 2

A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors

NCT ID: NCT06656390Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.Last updated: 2026-05-22

Summary

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.

Arms & interventions

DrugALK201
Administered intravenously, once every 3 weeks

Outcome measures

Primary

To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Time frame: Approximately 36 months

Secondary

To evaluate the pharmacokinetics (PK) of ALK201.
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK201
Time frame: Approximately 36 months
To evaluate the immunogenicity of ALK201.
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK201
Time frame: Approximately 36 months
To evaluate the biomarkers.
Time frame: Approximately 36 months

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No

Inclusion Criteria: * Men and women ≥18 and ≤75 years old on the day of signing the ICF * At least 1 measurable lesion per RECIST v1.1 * Expected survival ≥3 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 * Adequate organ function * Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms Exclusion Criteria: * Active or pre-existing autoimmune diseases that may relapse * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage * Allergies to any component of ALK201 or other monoclonal antibodies * Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening * Vaccinated with live vaccines within 4 weeks prior to the first dose Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study locations (4)

Denver Drug Development Unit

Denver, Colorado, 80218

Recruiting

Dr.Jason Henry · Contact

UCF Lake Nona Cancer Center

Orlando, Florida, 32827

Recruiting

Dr.Cesar Perez · Contact

University Medical Center New Orleans

New Orleans, Louisiana, 70112

Recruiting

Dr. Shou-Ching Tang · Contact

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Dr. Meredith Pelster · Contact