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| Name | Class |
|---|---|
| Akesobio | INDUSTRY |
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This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Safety run-in | Experimental | Multiple dose levels of YL201 will be explored in combination with Ivonescimab administered intravenously (IV) at a fixed dose.Participants receive YL201 and Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
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| Phase 2: Dose expansion | Experimental | YL201 will be administered at the selected RDE in combination with Ivonescimab administered IV at a fixed dose. Participants receive YL201+ Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | YL201 will be administered as IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | AEs are assessed based on NCI CTCAE v5.0. | Approximately within 36 months |
| Maximum tolerate dose(MTD) | Approximately within 36 months | |
| Recommended Dose for Expansion | Approximately within 36 months | |
| Objective Response Rate (ORR) | ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR). | Approximately within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) | Approximately within 36 months | |
| maximum concentration (Cmax) | Approximately within 36 months | |
| minimum concentration at trough (Ctrough) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MediLink Threrapeutics | Contact | +86 512 62858368 | clinicaltrials@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Ivonescimab | Drug | Ivonescimab will be administered as IV infusion. |
|
| Approximately within 36 months |
| Volume of distribution (Vd) | Approximately within 36 months |
| plasma clearance (CL) | Approximately within 36 months |
| half-life (t1/2) | Approximately within 36 months |
| Time to peak drug concentration (Tmax) | Approximately within 36 months |
| Investigator-assessed progression-free survival (PFS) | PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first | Approximately within 36 months |
| Investigator-assessed overall survival (OS) | OS defined as the time interval from the first study drug administration to death due to any cause. | Approximately within 36 months |
| Investigator-assessed disease control rate (DCR) | DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD). | Approximately within 36 months |
| Investigator-assessed time to response (TTR) | TTR defined as the time interval from the first study drug administration to the first documentation of response (CR or PR). | Approximately within 36 months |
| Investigator-assessed the depth of response (DpR) per RECIST v1.1 | The percentage change in target lesion size | Approximately within 36 months |
| number of subjects who are Anti-Drug Antibody (ADA)-positive at any time | Approximately within 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |