A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
NCT07622524 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 310
Last updated 2026-08-14
Summary
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
Conditions
Interventions
- DRUG
-
CS5007
CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-16
- Primary Completion
- 2028-01-31
- Completion
- 2029-01-31
Countries
- Australia
- China
Study Locations
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