An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Akeso
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Number of subjects with dose limiting toxicities (DLTs)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •ECOG status of 0 or 1
- •Life expectancy ≥ 3 months
- •Adequate organ function
- •Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
Exclusion Criteria
- •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
- •Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway
- •Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product
- •Current dependency on systemic therapy with glucocorticoids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product
- •Presence of spinal cord compression or active brain metastases
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- •History or presence of a serious hemorrhage or known bleeding tendency within 3 months
Arms & Interventions
AK119 in combination with AK112
AK119 and AK112, IV, every 3 weeks
Intervention: AK119 (Drug)
AK119 in combination with AK112
AK119 and AK112, IV, every 3 weeks
Intervention: AK112 (Drug)
Outcomes
Primary Outcomes
Number of subjects with dose limiting toxicities (DLTs)
Time Frame: During the first three weeks
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.
Objective Response Rate (ORR)
Time Frame: Up to 2 years
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
Number of subjects with adverse events (AEs)
Time Frame: From the time of informed consent signed through 90 days after the last dose of study drug.
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.
Secondary Outcomes
- Overall survival (OS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Time to response (TTR)(Up to 2 years)
- Progression free survival (PFS)(Up to 2 years)
- Time to progression (TTP)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)