A Phase 1/2 interventional study of YL242 and YL242; Pembrolizumab in Advanced Solid Tumor, sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. Recruiting at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 424 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →MediLink Therapeutics (Suzhou) Co., Ltd. is the lead sponsor of 23 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
Drug: YL242
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.
Drug: YL242; Pembrolizumab
Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
Drug: YL242; 5-FU; LV
Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.
Drug: YL242; Pembrolizumab; 5-FU
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.
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.
Objective 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
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MediLink Therapeutics (Suzhou) Co., Ltd.