NCT07197827 · MediLink Therapeutics (Suzhou) Co., Ltd.
A Study of YL242 in Subjects With Advanced Solid Tumors
What this study is about
This is a conducted at multiple hospitals, where both patients and doctors know the treatment given study to evaluate the safety and how well patients handle the treatment of YL242 treatment given alone and combination in participants with advanced solid malignant tumors.
View original scientific description
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.
Interventions
DRUG
YL242
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.
DRUG
YL242; Pembrolizumab
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.
DRUG
YL242; 5-FU; LV
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.
DRUG
YL242; Pembrolizumab; 5-FU
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 outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 carcinomat
Where
- New Haven, Connecticut
- Sarasota, Florida
- Boston, Massachusetts
- Grand Rapids, Michigan
- Nashville, Tennessee
- Houston, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations