Trials / Recruiting
RecruitingNCT06725381
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Detailed description
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SKB571 | SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first. |
Timeline
- Start date
- 2024-12-17
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-12-10
- Last updated
- 2026-01-07
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06725381. Inclusion in this directory is not an endorsement.