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
Qualifiers
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
Treatments tested in this trial
- AK119
- AK112
Treatment groups
87 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov