YL-13027 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title: A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 in Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

Part 1 (Phase Ia):

This is a dose escalation, 3 + 3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. Up to 4 cohorts of 3-6 patients each will be treated in part 1 of the study. One cycle is 28 days.

Part 2:

This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D.

Clinical Trial Description

3.1.3. Parts 1 and 2: Patients will receive study treatment until criteria for study termination are met.

A Safety Follow-up Visit will be conducted 30 days (±7 days) after the last dose of study treatment Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

Tumor response will be assessed by physical examination, computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator. Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Specific procedures to be performed during the study, as well as their prescribed times and associated visit windows, are outlined in the Schedule of Activities (SoA) see Appendix 1. Details of each procedure are provided in Section 7. The Safety Monitoring Committee (SMC) will monitor safety during the duration of the study. The SMC will make reviews based on Investigator site dose adjustments, adverse events, serious adverse events or discontinuation study treatment and make any appropriate recommendations to the Sponsor. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT05228600
• Study type: Interventional
• Source: Shanghai YingLi Pharmaceutical Co. Ltd.
• Contact: Meiyue Hong
• Phone: 13918087228
• Email: myhong@yl-pharma.com
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2022
• Completion date: December 1, 2023