Clinical trial NCT05235542: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors
Official title: A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Tumors
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors


Eligibility criteria: Inclusion Criteria:

1. 18 to 75 years old.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Undergone major surgery within 30 days prior to the first dose of study treatment.
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. History of severe bleeding tendency or coagulation disorder.

Primary outcomes:
measure: Number of patients with Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Maximum observed concentration (Cmax) of AK117 and AK104
timeFrame: From first dose of study drug to last dose of of study drug
measure: Minimum observed concentration (Cmin) of AK117 and AK104 at steady state
timeFrame: From first dose of study drug to last dose of of study drug
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of study drug through 30 days after last dose of study drug
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Liwei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: