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Phase 1
Age: 18Years - 74Years
All Genders
ID06158477

Phase I Study to Evaluate Safety, Tolerability, and How JYP0035 Capsule Works in the Body in Adults with Advanced Solid Tumors

Led by Chengdu JOYO pharma Co., Ltd. · Updated on 2024-11-18

75

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes the JYP0035 capsule in patients with advanced solid tumors. This Phase I clinical trial focuses on understanding the safety profile and pharmacokinetics of JYP0035 in this group. The trial addresses important questions about the drugs effects and behavior in the body for patients with serious cancers. Participants will receive JYP0035 capsules in two parts first, an escalating dose phase PART-1 to find the right dose, followed by a dose-expansion phase PART-2 where the selected dose is given as monotherapy. This study has a single group design, meaning all participants receive the JYP0035 capsule without comparison to another treatment or placebo. During the trial, participants will be monitored for side effects and how much drug exposure they have from 8 weeks after the first dose up to 52 weeks. Researchers will assess adverse events and measure drug levels in the body over this time. The study lasts up to about one year, with regular safety checks and evaluations to understand the treatments effects and tolerability.

CONDITIONS

Brief Title

A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Research Team

Z

Zhang Jian, MD

H

Huang Hongming, MD

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