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

NCT07631793 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-06-08

No results posted yet for this study

Summary

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

Conditions

  • Malignant Neoplasms

Interventions

DRUG

YKYY031 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.

DRUG

YKYY031 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.

Sponsors & Collaborators

  • Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-12-08
Completion
2030-12-07

Countries

  • China

Study Locations

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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 NCT07631793 on ClinicalTrials.gov