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Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The dose escalation and expansion stage of AK129 combined with chemotherapy; | Experimental | Part 1: The dose escalation stage： 3 dose groups of AK129 were set up, combination with chemotherapy of XELOX,followed by AK129 and capecitabine maintenance; Part 2：The dose expansion stage： Two to three dosing regimens were set for expansion of AK129 in combination with XELOX. |
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| The dose escalation and expansion stage of AK129 combined with chemotherapy with cadonilimab | Experimental | Part 1:The dose escalation stage： 3 dose groups of AK129 were set up, combination with cadonilimab and chemotherapy of XELOX,followed by AK129 and cadonilimab maintenance; Part 2:The dose expansion stage： Two to three dosing regimens were set for expansion of AK129 in combination with cadonilimab and chemotherapy of XELOX. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: AK129 Drug：oxaliplatin Drug：capecitabine | Drug | AK129 is administered intravenously according to the frequency every three weeks(Q3W) and different dosage of administration at different stages.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events(AE) | Incidence and severity of AEs is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab | Up to approximately 2 years |
| Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR) | Incidence of SAE and SUSAR is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab | Up to approximately 2 years |
| Incidence of dose-limiting toxicity(DLT) | The purpose of DLT is to find the Phase II recommended dose(RP2D) or Maximum Tolerated Dose(MTD) | Up to approximately 2 years |
| Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension | Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab | Up to approximately 2 years |
| Objective Solution Rate (ORR) based on RECIST v1.1 | The purpose of ORR is aim to evaluate the antitumor effect,and ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate(DCR) | Disease control rate(DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR or PR or stable disease(SD) per RECIST v1.1. | 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 | |
|---|---|---|---|---|
| Xiao Xu, MD, PhD | Contact | +86 (0760) 8987 3999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangdong Cheng, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hanzhou | Zhejiang | 310005 | China |
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Phase 1b/II, open-label, 2-part, multicenter, non-randomized, multiple-dose study
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| Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine | Drug | AK129 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages. Cadonilimab is administered intravenously according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W. |
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Duration of response(DoR) is defined as the period from the first documentation of confirmed response(CR or PR) to the first documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first.
| Up to approximately 2 years |
| time to response(TTR) | Time to response(TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR. | Up to approximately 2 years |
| progression-free survival(PFS) | Progression-free survival(PFS) is defined as the time from the first dose of investigational products until documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| overall survival(OS) | Overall survival(OS) is defined as the time from the first dose of investigational products until death due to any cause. | Up to approximately 2 years |
| Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument | Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument to evaluate the Pharmacokinetics(PK). | Up to approximately 2 years |
| Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab | Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | Up to approximately 2 years |