MedTrace Logo

A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors

NCT05457517 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-09-27

No results posted yet for this study

Summary

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w）.

Conditions

Interventions

DRUG

YL-13027，Sintilimab

YL-13027 combined with Sintilimab will be used as a cycle for 21 days. YLl-13027 is administered orally twice a day. Starting dose of YL-13027 is 240mg/d，with escalation to 360mg/d in phase Ib, and RP2D was administered orally twice a day in phase II. Sindilizumab is administered intravenously 200mg every three weeks

Sponsors & Collaborators

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Hanying Bao, PhD · Shanghai YingLi Pharmaceutical Co. Ltd.

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
2022-09-24
Primary Completion
2024-06-01
Completion
2025-01-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05457517 on ClinicalTrials.gov