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Study of ALK202 for Advanced Solid Tumors

This study is testing a new drug called ALK202 in people with advanced solid tumors (cancers that start in organs like the breast, lung, or colon). It's the first time ALK202 is being given to humans. The main goals are to see how safe ALK202 is, what side effects it might cause, and how much of the drug stays in your body. Researchers also want to find the best dose of ALK202 for future studies. You might be able to join if you are between 18 and 75 years old, have advanced solid tumors, and meet other health requirements. The study plans to enroll 234 participants, but its current status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving ALK202. It is a first-in-human study that plans to enroll 234 participants.
What's involved
You would receive ALK202 intravenously (through a vein) once every three weeks. The study will evaluate safety and tolerability for approximately 36 months.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate safety and tolerability for 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.

NCT06707610

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Shanghai Allink Biotherapeutics Co., Ltd.
~234 participants
Updated 2025-03-12 on ClinicalTrials.gov
What's tested:ALK202

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.
Measured over Approximately 36 months

Conditions

Advanced Cancer
Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT06707610

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • D&H Cancer Research Center Llc

    Margate, Floridastudy coordinator listed

    Recruiting

  • Macquarie University

    Sydney, New South Wales, Australiastudy coordinator listed

    Recruiting

  • Next Oncology

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Scientia Clinical Research Ltd

    Randwick, New South Wales, Australiastudy coordinator listed

    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

Shuntong Duan
[email protected]
8618005141727
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
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 (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.

Exclusion

Received organ transplant or hematopoietic stem cell transplant previously
Vaccinated with live vaccines within 4 weeks prior to the first dose
Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
Pregnant or lactating women
Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).

What this trial measures

  • To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 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.