NCT06801470

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-Label, First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD 001 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (estimated)
• Sponsor: CD (Suzhou) Biopharma Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CD-001	CD-001 administered as an intravenous (IV) infusion.

Timeline

• Start date: 2025-01-08
• Primary completion: 2028-01-01
• Completion: 2028-06-01
• First posted: 2025-01-30
• Last updated: 2025-02-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study