A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
NCT06158477 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2024-11-18
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
- DRUG
-
JYP0035 Experimental Drug Treatment
Single dose intervention
Sponsors & Collaborators
-
Guangzhou JOYO Pharma Co., Ltd
collaborator INDUSTRY -
Chengdu JOYO pharma Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-12-01
- Completion
- 2027-12-01
Countries
- China
Study Locations
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