Evaluating ALK202 for advanced solid tumors
A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
This study is testing a new drug called ALK202 to see if it is safe and effective for adults with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Allink Biotherapeutics Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Margate, Florida and 3 other locations) |
| Trial ID | NCT06707610 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 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.
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 primary central nervous system malignancies or those who have received organ transplants 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 first-in-human therapies for advanced cancers have shown promise, indicating potential for success with this approach.
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 * 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 this trial is running
Margate, Florida and 3 other locations
- 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
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.