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A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK130 | Experimental | Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK130 | Drug | IV infusion, specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of participants with adverse events (AEs) | From time ICF is signed until 90 days after last dose of AK130 | |
| Number of participants with DLTs | During the first four weeks of treatment with AK130 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Up to approximately 2 years | |
| Disease control rate (DCR) | Up to approximately 2 years | |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu | The Cancer Hospital Affiliated to Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | China |
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| Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to response (TTR) | Up to approximately 2 years |
| Maximum observed concentration (Cmax) of AK130 | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. | From first dose of study drug through end of treatment (up to approximately 2 years) |
| Minimum observed concentration(Cmin) of AK130 | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. | From first dose of study drug through end of treatment (up to approximately 2 years) |
| Area under the curve (AUC) of AK130 for assessment of pharmacokinetics | The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration. | From first dose of study drug through end of treatment (up to approximately 2 years) |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of study drug through 30 days after last dose of study drug |