Trials / Recruiting
RecruitingNCT06245122
A Study of CS23546 in Subjects With Advanced Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- Sponsor
- Chipscreen Biosciences, Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.
Detailed description
This study is a single arm, open phase I trial, consisting of a dose escalation phase (single dose+multiple doses) and a dose expansion phase, accompanied by pharmacokinetic and pharmacokinetic studies. The first visit period (21 days) of single dose and multiple doses during the dose-increasing phase is the DLT observation period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CS23546 | Tablets administered orally. |
Timeline
- Start date
- 2024-03-27
- Primary completion
- 2027-02-28
- Completion
- 2027-05-31
- First posted
- 2024-02-07
- Last updated
- 2026-04-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06245122. Inclusion in this directory is not an endorsement.