A Study of YL242 in Subjects With Advanced Solid Tumors
NCT ID: NCT07197827
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
424 participants
INTERVENTIONAL
2025-09-22
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 and Part 2: Mono Dose Escalation & Expansion
Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
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.
Part 3 and 4: Combination Dose Escalation & Expansion
Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.
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.
Part 5: Combination Dose Optimization and Expansion
Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
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.
Part 6: Combination Dose Optimization and Expansion
Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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MediLink Therapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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US-201
New Haven, Connecticut, United States
US-202
Sarasota, Florida, United States
US-204
Boston, Massachusetts, United States
US-206
Grand Rapids, Michigan, United States
US-205
Nashville, Tennessee, United States
US-203
Houston, Texas, United States
US-207
San Antonio, Texas, United States
AUS-101
Liverpool, New South Wales, Australia
AUS-102
Darlinghurst, Victoria, Australia
AUS-104
Fitzroy, Victoria, Australia
AUS-103
Heidelberg, Victoria, Australia
AUS-105
Nedlands, Western Australia, Australia
CN-303
Harbin, Heilongjiang, China
CN-301
Shanghai, Shanghai Municipality, China
CN-302
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
study coordinator
Role: primary
Other Identifiers
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YL242-INT-101-01
Identifier Type: -
Identifier Source: org_study_id