A Study of YL242 in Subjects With Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT07197827

This multicenter, open-label study assesses the safety and tolerability of YL242, alone and in combination, in adults with advanced solid tumors. Eligible participants must have an ECOG PS of 0 or 1 and adequate organ function. Interventions include YL242 alone or with Pembrolizumab, 5-FU, and LV, administered via IV infusion. Participants have varying prior treatment histories based on tumor type.

Patient Parameters

Program Overview

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.

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

Locations

FACILITYZIPCITYSTATE
US-20106519New HavenConnecticut
US-20234232SarasotaFlorida
US-20402215BostonMassachusetts
US-20649546Grand RapidsMichigan
US-20537203NashvilleTennessee
US-20377030HoustonTexas
US-20778229San AntonioTexas

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