Evaluating ALK201 for advanced solid tumors
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
PHASE1; PHASE2 · Shanghai Allink Biotherapeutics Co., Ltd. · NCT06656390
This study is testing a new drug called ALK201 to see if it is safe and effective for adults with advanced solid tumors.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Allink Biotherapeutics Co., Ltd. (industry) |
| Locations | 2 sites (Wollongong, New South Wales and 1 other locations) |
| Trial ID | NCT06656390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with measurable advanced solid tumors and an expected survival of at least three months.
Not a fit: Patients with active autoimmune diseases, certain effusions, or primary central nervous system malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies evaluating similar first-in-human therapies have shown promise, but this specific approach with ALK201 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wollongong, New South Wales and 1 other locations
- Cancer Care Wollongong — Wollongong, New South Wales, Australia (RECRUITING)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: ALK Tang
- Email: xftang@allinkbio.com
- Phone: +8618502921630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Cancer, Advanced Solid Tumors, First-in-human