Trials / Completed
CompletedNCT03475251
A Study of CS1003 in Subjects With Advanced Solid Tumors
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- CStone Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CS1003 | In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type. |
| BIOLOGICAL | CS1003 | CS1003 to be intravenously administered at the dose level determined during the dose escalation part |
| DRUG | Regorafenib | Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2021-05-31
- Completion
- 2021-05-31
- First posted
- 2018-03-23
- Last updated
- 2022-02-18
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03475251. Inclusion in this directory is not an endorsement.