A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Cancer, Advanced Solid Tumor
In brief
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
Key facts
- Study ID
- NCT06707610
- Run by
- Shanghai Allink Biotherapeutics Co., Ltd.
- People needed
- 234
- Starts
- 2025-02-10
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-03-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- D&H Cancer Research Center Llc — Margate, Florida, United States (enrolling)
- Next Oncology — Fairfax, Virginia, United States (enrolling)
- Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (enrolling)
- Macquarie University — Sydney, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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