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Terminated due to sponsor strategic development reprioritization.
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This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK119 + AK112 | Experimental | Subjects will receive AK119 plus AK112 via intravenously (IV) Q3W, up to 2 years. |
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| AK119 + AK112 + Pemetrexed + Carboplatin | Experimental | Subjects will receive AK119 and AK112 plus pemetrexed and carboplatin via intravenously (IV) Q3W, up to 4 cycles. Afterward, AK119 and AK112 plus pemetrexed will continue to be treated up to 2 years. |
|
| AK112 | Experimental | Subjects will receive AK112 monotherapy via intravenously (IV) Q3W, up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK119 | Drug | AK119 IV every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with dose limiting toxicities (DLTs) | DLTs will be assessed during the first 3 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period. | During the first 3 weeks |
| Number of subjects with adverse events (AEs) | AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. | From the time of informed consent signed through 90 days after the last dose of study drug |
| Objective response rate (ORR) | ORR is defined as the proportion of subjects with confirmed CR or confirmed PR. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1). | Up to 2 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu, PhD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | China |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| AK112 | Drug | AK112 IV every 3 weeks. |
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| Pemetrexed | Drug | Pemetrexed IV every 3 weeks. |
|
| Carboplatin | Drug | Carboplatin IV every 3 weeks. |
|
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1). |
| Up to 2 years |
| Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first. | Up to 2 years |
| Time to response (TTR) | TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1). | Up to 2 years |
| Overall survival (OS) | OS defined as the time from the first dose to death from any cause. | Up to 2 years |
| Maximum observed concentration (Cmax) of AK119 and AK112 | The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration. | From first dose of study drug through last dose |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs). | From first dose of study drug through last dose |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |