Trials / Unknown
UnknownNCT04472858
A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
Detailed description
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donafenib | dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study. |
| DRUG | CS1001 | CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2020-07-16
- Last updated
- 2022-11-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04472858. Inclusion in this directory is not an endorsement.