Evaluating ALK201 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 ALK201 in adult patients with advanced solid tumors. The study involves a dose escalation and expansion approach to identify the recommended doses for future clinical studies. Participants will receive ALK201 as a monotherapy, and the study aims to gather critical data on its effectiveness and safety profile.

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
* 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

Where it's running

• Denver Drug Development Unit
  Denver, Colorado, United States Recruiting
• UCF Lake Nona Cancer Center
  Orlando, Florida, United States Recruiting
• University Medical Center New Orleans
  New Orleans, Louisiana, United States Recruiting
• Sarah Cannon Research Institute Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Cancer Care Wollongong
  Wollongong, New South Wales, Australia Recruiting
• Sunshine Coast University Private Hospital
  Birtinya, Queensland, Australia Recruiting

Study contacts

• Study coordinator: ALK Tang
• Email: xftang@allinkbio.com
• Phone: +8618502921630

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.