A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
NCT06707610 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 234
Last updated 2025-03-12
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.
Conditions
- Advanced Cancer
- Advanced Solid Tumor
Interventions
- DRUG
-
ALK202
Administered intravenously, once every 3 weeks
Sponsors & Collaborators
-
Shanghai Allink Biotherapeutics Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-10
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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