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Phase I-II

A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors

  • Study HIC#:2000040679
  • Last Updated:12/08/2025

This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    • Aged ≥18 years.
    • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
    • Adequate organ and bone marrow function
    • Tumor type:

    Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy

    Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;

    Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy

    Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy

    Exclusion Criteria:

    • Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
    • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
    • Clinically significant concomitant pulmonary disease
    • A history of leptomeningeal carcinomatosis or carcinomatous meningitis
    • Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: