A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activit
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 identi
| Condition(s) | Advanced Cancer, Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Allink Biotherapeutics Co., Ltd. |
| Locations | Margate, Florida, United States; Fairfax, Virginia, United States; Randwick, New South Wales, Australia; Sydney, New South Wales, Australia |
| Start date | 2025-02-10 |
| NCT ID | NCT06707610 |
| Official listing | https://clinicaltrials.gov/study/NCT06707610 |