A Study of YL242 in Subjects With Advanced Solid Tumors

NCT07197827
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
424
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Start date
2025-09-22
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Number of sites
15
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Summary
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.
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Short title
A Study of YL242 in Subjects With Advanced Solid Tumors
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Official title
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.
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-11-01
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First posted
2025-09-29
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Registry last updated
2025-12-24
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Primary completion date
2028-09-01
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Start date
2025-09-22
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Participants
424
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Participant count basis
Estimated
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Planned participants
424
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Protocol amendments
1
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Number of sites
15
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07197827
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ClinicalTrials.gov ID
NCT07197827
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)

    Timeframe: Approximately within 36 months

    Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  2. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Baseline up to 42 days post last patients last dose, approximately within 36 months

    AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.

  1. Area Under the Serum Concentration Time Curve (AUC) of YL242

    Timeframe: Approximately within 36 months

  2. Maximum Plasma Concentration (Cmax) of YL242

    Timeframe: Approximately within 36 months

  3. Time to Maximum Plasma Concentration (Tmax) of YL242

    Timeframe: Approximately within 36 months

  4. Incidence of anti-YL242 antibody

    Timeframe: Approximately within 36 months

  5. Terminal Elimination Half-life (t1/2) of Serum YL242

    Timeframe: Approximately within 36 months

  6. Disease Control Rate (DCR)

    Timeframe: Approximately within 36 months

    Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • US-201New Haven, United StatesNot yet recruiting
  • US-202Sarasota, United StatesRecruiting
  • US-204Boston, United StatesNot yet recruiting
  • US-206Grand Rapids, United StatesRecruiting
  • US-205Nashville, United StatesRecruiting
  • US-203Houston, United StatesNot yet recruiting
  • US-207San Antonio, United StatesNot yet recruiting
  • AUS-101Liverpool, AustraliaNot yet recruiting
  • AUS-102Darlinghurst, AustraliaRecruiting
  • AUS-104Fitzroy, AustraliaNot yet recruiting
  • AUS-103Heidelberg, AustraliaNot yet recruiting
  • AUS-105Nedlands, AustraliaNot yet recruiting
  • CN-303Harbin, ChinaRecruiting
  • CN-301Shanghai, ChinaRecruiting
  • CN-302Hangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Targets (3)