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NCT Number: NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

AUS-101, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YL242

Drug

The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.

YL242; Pembrolizumab

Drug

The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.

YL242; 5-FU; LV

Drug

The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.

LV and 5-FU will be sequentially administered following YL242.

YL242; Pembrolizumab; 5-FU

Drug

The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion.

Pembrolizumab and 5-FU will be administered in sequence after YL242.

Primary outcomes

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

    Time frame: 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)

    Time frame: 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.

Secondary outcomes

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

    Time frame: Approximately within 36 months

  2. Maximum Plasma Concentration (Cmax) of YL242

    Time frame: Approximately within 36 months

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

    Time frame: Approximately within 36 months

  4. Incidence of anti-YL242 antibody

    Time frame: Approximately within 36 months

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

    Time frame: Approximately within 36 months

  6. Disease Control Rate (DCR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Medilink Study Team

CONTACT

[email protected]

+86 0512-62858368

Sponsors and collaborators

Lead sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 29, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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