Trials / Recruiting
RecruitingNCT06158477
A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
An Open-label Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Chengdu JOYO pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are: * What is the safety profile of JYP0035 when administered to these patients? * How does JYP0035 capsule behave in the body pharmacokinetically? Participants will: * Receive escalating doses of JYP0035 capsule during the dose-escalation phase (PART-1). * Continue with the identified dose in the dose-expansion phase (PART-2). As this is a single-arm study, there is no comparison group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JYP0035 Experimental Drug Treatment | Single dose intervention |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2023-12-06
- Last updated
- 2024-11-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06158477. Inclusion in this directory is not an endorsement.