Trials / Recruiting
RecruitingNCT06499350
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
Detailed description
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FC084CSA+Tislelizumab combination (dose escalation) | Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy |
| DRUG | RP2D of FC084CSA+Tislelizumab combination (dose expansion) | RP2D of FC084CSA+fixed dose Tislelizumab combination therapy |
Timeline
- Start date
- 2024-11-13
- Primary completion
- 2026-07-01
- Completion
- 2026-10-01
- First posted
- 2024-07-12
- Last updated
- 2026-03-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06499350. Inclusion in this directory is not an endorsement.