Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations
Age ≥ 18 years and ≤ 75 years
Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
Measurable lesion based on RECIST v1.1
Disqualifiers
Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent
Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study
Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational product
In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanism
Trial design
Design model
Sequential
Treatments tested in this trial
AK119
DrugAK119 is an anti-CD73 monoclonal antibody.
AK112
DrugAK112 is a bispecific monoclonal antibody against VEGF and PD-1.
Treatment groups
87 Participants
are divided into 1 treatment groupGroup A: AK119 in combination with AK112Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first three 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.
Time frame
During the first three weeks2
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.
Time frame
From the time of informed consent signed through 90 days after the last dose of study drug.3
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
Time frame
Up to 2 yearsSecondary outcomes
1
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).
Time frame
Up to 2 years2
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame
Up to 2 years3
Duration of response (DoR)
Duration of response 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.
Time frame
Up to 2 years4
Time to response (TTR)
Time to response (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).
Time frame
Up to 2 years Source ClinicalTrials.gov