A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors
- Conditions
- Advanced Malignant Tumors
- Interventions
- Registration Number
- NCT05229497
- Lead Sponsor
- Akeso
- Brief Summary
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 114
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18 to 75 years old.
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Have a life expectancy of at least 3 months.
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor.
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Phase II:
Cohort 1 and 2 :
A. Has histologically confirmed recurrent or metastatic HNSCC who had failed only first-line platinum-containing therapy.
B. Has histologically confirmed recurrent or metastatic HNSCC with PD-L1 positive (CPS≥1) without prior systemic antitumor therapy.
Cohort 3: Has histologically confirmed recurrent or metastatic HNSCC without prior systemic antitumor therapy.
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Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
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Has adequate organ function.
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Active central nervous system (CNS) metastases.
- History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active Hepatitis B or Hepatitis C.
- Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
- History of severe bleeding tendency or coagulation disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase Ib#Dosage regimen 2# AK112 Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW) Phase Ib#Dosage regimen 1# AK112 Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW) Phase Ib#Dosage regimen 1# AK117 Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW) Phase Ib#Dosage regimen 2# AK117 Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW) Phase II#Cohort 1# AK112 Head and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W) Phase II#Cohort 2# AK112 HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose) Phase II#Cohort 2# AK117 HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose) Phase II#Cohort 3# 5-Fluorouracil HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil Phase II#Cohort 3# AK112 HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil Phase II#Cohort 3# AK117 HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil Phase II#Cohort 3# Cisplatin HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil Phase II#Cohort 3# Carboplatin HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 2 years Number of patients with Adverse Events (AEs) Up to approximately 2 years Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Number of patients experiencing dose-limiting toxicities (DLTs) During the first 3 weeks
- Secondary Outcome Measures
Name Time Method Time to response (TTR) Up to approximately 2 years Progression free survival (PFS) Up to approximately 2 years Overall survival (OS) Up to approximately 2 years Disease control rate (DCR) Up to approximately 2 years Duration of Response (DOR) Up to approximately 2 years
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China