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A Study of ALK201 for Advanced Solid Tumors

This study is testing a new drug called ALK201 in people with advanced solid tumors. It's the first time this drug is being given to humans. Researchers want to see how safe ALK201 is, how well your body handles it (tolerability), and how it moves through your body (pharmacokinetics). They also want to see if it can shrink tumors. The study aims to find the highest safe dose and the best dose to use in future studies. You might be able to join if you are between 18 and 75 years old, have advanced solid tumors that can be measured, and are expected to live at least 3 months. The study plans to enroll 202 participants.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving ALK201. It will involve about 202 participants across multiple locations.
What's involved
ALK201 will be given through a vein (intravenously) once every three weeks. The study will last approximately 36 months to evaluate safety and tolerability.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study will be measured over approximately 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06656390

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Shanghai Allink Biotherapeutics Co., Ltd.
~202 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:ALK201

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Approximately 36 months

Conditions

Advanced Cancer
Advanced Solid Tumors

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Solid Neoplasm

NCT06656390

Where you'd take part

This study runs at 38 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, Chinastudy coordinator listed

    Recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, Chinano site contact published

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, Chinano site contact published

    Recruiting

  • Cancer Care Wollongong

    Wollongong, New South Wales, Australiano site contact published

    Recruiting

  • Cancer Hospital Of Shantou University Medical College

    Shantou, Guangdong, Chinano site contact published

    Recruiting

  • ChongQing University Cancer Hospital

    Chongqing, Chinano site contact published

    Recruiting

  • Denver Drug Development Unit

    Denver, Coloradono site contact published

    Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

ALK Tang
[email protected]
+8618502921630
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.Approximately 36 months

    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.