Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Details

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 indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in cancer cells or patient derived xenograft models.

Therefore, in order to meet the huge unmet medical needs in the field of gastrointestinal cancer treatment, it is planned to conduct the first human phase I clinical study of YL217 in patients with advanced solid tumors.

Keywords

Advanced Solid Tumor, Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
  • Able and willing to comply with protocol visits and procedures
  • Aged ≥ 18 years
  • Eastern Cooperative Oncology Group performance status (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 paraffin embedded (FFPE) tissue from prior biopsy.

You CAN'T join if...

  • Prior treatment with an agent targeting CDH17
  • Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
  • Have received a topoisomerase I inhibitor within protocol defined time before the first dose of study drug.
  • Have received an ADC consisting of a topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study.
  • Inadequate washout period for prior anticancer treatment before the first dose of study drug
  • Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study.
  • Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
  • Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
  • Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  • A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
  • Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Uncontrolled third-space fluid that requires repeated drainage.
  • Digestive system disease that may cause bleeding, perforation, jaundice, gastrointestinal obstruction.
  • An active tuberculosis based on medical history.
  • Known human immunodeficiency virus (HIV) infection.
  • Active hepatitis C infection.

Locations

  • UCLA Hematology/Oncology - Santa Monica not yet accepting patients
    Santa Monica California 90404 United States
  • UT Health San Antonio - Mays Cancer Center not yet accepting patients
    San Antonio Texas 78229 United States
  • Peking Union Medical College Hospital accepting new patients
    Beijing Bejing 100730 China
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine not yet accepting patients
    Shanghai Shanghai 200025 China
  • Tianjin Medical University Cancer Institute & Hospital not yet accepting patients
    Tianjin Tianjin 300060 China
  • Zhejiang Cancer Hospital not yet accepting patients
    Hangzhou Zhejiang 310022 China

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
ID
NCT06859762
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated