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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 and Part 2: Mono Dose Escalation & Expansion | Experimental | Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency. |
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| Part 3 and 4: Combination Dose Escalation & Expansion | Experimental | 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. |
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| Part 5: Combination Dose Optimization and Expansion | Experimental | Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution. |
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| Part 6: Combination Dose Optimization and Expansion | Experimental | Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline up to 42 days post last patients last dose, approximately within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration Time Curve (AUC) of YL242 | Approximately within 36 months | |
| Maximum Plasma Concentration (Cmax) of YL242 | Approximately within 36 months | |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medilink Study Team | Contact | +86 0512-62858368 | clinicaltrials@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US-201 | Not yet recruiting | New Haven | Connecticut | 06519 | United States |
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| 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. |
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| 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. |
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| 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. |
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| Time to Maximum Plasma Concentration (Tmax) of YL242 |
| Approximately within 36 months |
| Incidence of anti-YL242 antibody | Approximately within 36 months |
| Terminal Elimination Half-life (t1/2) of Serum YL242 | 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. | Approximately within 36 months |
| US-202 | Recruiting | Sarasota | Florida | 34232 | United States |
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| US-204 | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| US-206 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| US-205 | Recruiting | Nashville | Tennessee | 37203 | United States |
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| US-203 | Not yet recruiting | Houston | Texas | 77030 | United States |
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| US-207 | Not yet recruiting | San Antonio | Texas | 78229 | United States |
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| AUS-101 | Not yet recruiting | Liverpool | New South Wales | 2170 | Australia |
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| AUS-102 | Recruiting | Darlinghurst | Victoria | 2010 | Australia |
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| AUS-104 | Not yet recruiting | Fitzroy | Victoria | 3065 | Australia |
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| AUS-103 | Not yet recruiting | Heidelberg | Victoria | 3084 | Australia |
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| AUS-105 | Not yet recruiting | Nedlands | Western Australia | 6009 | Australia |
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| CN-303 | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| CN-301 | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| CN-302 | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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