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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
424
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.
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.
US-201
New Haven, Connecticut, United States
NOT_YET_RECRUITINGUS-202
Sarasota, Florida, United States
RECRUITINGObjective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)
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.
Time frame: Approximately within 36 months
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.
Time frame: Baseline up to 42 days post last patients last dose, approximately within 36 months
Area Under the Serum Concentration Time Curve (AUC) of YL242
Time frame: Approximately within 36 months
Maximum Plasma Concentration (Cmax) of YL242
Time frame: Approximately within 36 months
Time to Maximum Plasma Concentration (Tmax) of YL242
Time frame: Approximately within 36 months
Incidence of anti-YL242 antibody
Time frame: Approximately within 36 months
Terminal Elimination Half-life (t1/2) of Serum YL242
Time frame: Approximately within 36 months
Disease Control Rate (DCR)
Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.
Time frame: Approximately within 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
US-204
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUS-206
Grand Rapids, Michigan, United States
RECRUITINGUS-205
Nashville, Tennessee, United States
RECRUITINGUS-203
Houston, Texas, United States
NOT_YET_RECRUITINGUS-207
San Antonio, Texas, United States
NOT_YET_RECRUITINGAUS-101
Liverpool, New South Wales, Australia
NOT_YET_RECRUITINGAUS-102
Darlinghurst, Victoria, Australia
RECRUITINGAUS-104
Fitzroy, Victoria, Australia
NOT_YET_RECRUITING...and 5 more locations