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A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK137 | Experimental | Each subject will receive a single dose of AK137 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 |
|---|---|---|---|---|
| AK137 | Drug | IV infusion, specified dose on specified days. |
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| Measure | Description | Time Frame |
|---|---|---|
| AEs | Incidence and severity of participants with adverse events | From time ICF is signed until 90 days after last dose of AK137 |
| DLT | During the first 28-day of treatment with AK137 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 2 years | |
| Disease Control Rate (DCR) | Up to approximately 2 years | |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xufang Yu | Contact | +86(0760)89873999 | clinicaltrials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | China |
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| Up to approximately 2 years |
| Time to response (TTR) | Up to approximately 2 years |
| Progression Free Survival (PFS) | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 2 years |
| Cmax of AK137 | From first dose of study drug through end of treatment (up to approximately 2 years) |
| Cmin of AK137 | 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 |