Evaluating ALK202 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multicenter study designed to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ALK202 in adults with advanced solid tumors. Participants will receive ALK202 as a monotherapy, and the study aims to determine the recommended doses for future clinical trials. The study will involve dose escalation and expansion phases to gather comprehensive data on the drug's effects.

Why it matters

Who can join: the full rules

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
* 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 Criteria:

* 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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• D&H Cancer Research Center Llc
  Margate, Florida, United States Recruiting
• Next Oncology
  Fairfax, Virginia, United States Recruiting
• Scientia Clinical Research Ltd
  Randwick, New South Wales, Australia Recruiting
• Macquarie University
  Sydney, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Shuntong Duan
• Email: stduan@allinkbio.com
• Phone: 8618005141727

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.