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Study on the Safe Dosage and Therapeutic Effect of the Drug YY2201 Tablets on Patients With Advanced Cancer

NCT06976931 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-16

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are:

What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors? What is the anti-tumor efficacy of YY2201 in patients with advanced solid tumors This is a multicenter, open-label, dose-escalation phase I study.

Participants will:

Start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle Perform radiography tumor assessments at screening visit every 2 cycles. Keep a diary of their symptoms.

Conditions

Interventions

DRUG

YY2201

This is a multicenter, open-label, dose-escalation phase I study. participants will receive one single target dose of YY2201 on Cycle 0 Day 1 (C0D1) to observe safety and collect PK blood samples up to 48 h post-dose. On the third day after the first dose (Cycle 1 Day 1, C1D1), subjects will start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle.

Sponsors & Collaborators

  • Jiangsu YaYao Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2027-04-05
Completion
2027-10-11
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976931 on ClinicalTrials.gov