A Phase Ia/Ib, Multicenter and Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Anti-PD-1 and CD73 Bispecific Antibody AK131 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- AK131
- Conditions
- Solid Tumor
- Sponsor
- Akeso
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events (AEs)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written and signed informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- •Life expectancy ≥3 months.
- •Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- •Subject must have at least one measurable lesion according to RECIST Version1.
- •Adequate organ function.
- •Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.
Exclusion Criteria
- •Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
- •Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- •Receipt of any anti-CD73 treatment.
- •Anticancer therapy within 4 weeks prior to the first dose of investigational product.
- •Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- •Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after treatment.
- •Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Subjects whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the study.
- •Toxicities of prior anticancer therapy have not resolved to ≤ Grade
- •Patients with clinically significant cardio-cerebrovascular disease.
Arms & Interventions
AK131
Subjects will receive AK131 via intravenously (IV) Q2W or Q3W, up to 2 years
Intervention: AK131
Outcomes
Primary Outcomes
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.
Number of subjects with dose limiting toxicities (DLTs)
Time Frame: During the first 4 weeks
DLTs will be assessed during the first 4 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.
Secondary Outcomes
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of study drug through 30 days after last dose of study drug)
- Time to response (TTR)(Up to approximately 2 years)
- Serum PK concentration of AK131(From first dose of study drug through 30 days after last dose of study drug)
- Objective response rate (ORR)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of Response (DoR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)