A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors

MediLink Therapeutics (Suzhou) Co., Ltd.

Summary

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Description

YL217 is an antibody-drug conjugate (ADC) that targets CDH17 (Cadherin-17) protein and is being developed for the treatment of cancer. YL217 is comprised of three components: 1) YL217-mAb, a CDH17-targeting recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody, 2) YL0010014, a topoisomerase I inhibitor, and 3) an enzymatically cleavable methylsulfonyl pyrimidine tripeptide drug linker. The in vivo anti-tumor efficacy of YL217 was evaluated in immune-deficient mice bearing human colorectal cancer, gastric cancer and patient derived colorectal cancer xenograft tumors. The results i…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Informed of the study before the start of the study and voluntarily sign their name and date in the ICF * Able and willing to comply with protocol visits and procedures * Age≥ 18 years * ECOG PS of 0 or 1 * Tumor types as below: For Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor. For Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease) * Adequate organ and bone marrow function. * Have at least 1 extracranial measurable tumor lesion. * Adequate archival formalin-fixed paraffi…

Interventions

Drug
YL217
Patients will be treated with YL217 intravenous(IV)infusion.
Drug
YL217
Patients will be treated with YL217 intravenous(IV)infusion.
Drug
YL217
Patients will be treated with YL217 intravenous(IV)infusion.

Locations (19)

Mayo Clinic Arizona
Phoenix, Arizona
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California
Yale Cancer Center
New Haven, Connecticut
The University of Kansas Cancer Center (KUCC)
Kansas City, Kansas
University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology
Baltimore, Maryland
Karmanos Cancer Institute
Detroit, Michigan