RecruitingPhase 1NCT07631793

Phase I Clinical Trial of YKYY031 for Injection in Patients With Advanced Solid Tumors

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YKYY031 for Injection in Patients With Advanced Solid Tumors


Sponsor

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Enrollment

76 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I study of YKYY031 for injection in patients with advanced solid tumors


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called YKYY031 group (the first stage) and a drug called YKYY031 group (the second stage) for people with malignant neoplasms. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYKYY031 group (the first stage)

Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.

DRUGYKYY031 group (the second stage)

Based on the results of the dose-escalation trial, 1-2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combination with other drugs. Eligible participants will be sequentially assigned to dose groups B1 to B2 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.


Locations(2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07631793


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