Advanced Malignant Tumors
Conditions
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
Interventions
DRUGAK112
IV infusion,Specified dose on specified days
DRUGAK117
IV infusion,Specified dose on specified days
DRUGCarboplatin
IV infusion,Specified dose on specified days
DRUGCisplatin
IV infusion,Specified dose on specified days
DRUG5-Fluorouracil
IV infusion,Specified dose on specified days
DRUGGemcitabine
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old. 2. Have a life expectancy of at least 3 months. 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor. 5. Phase II: Subjects were patients with recurrent/metastatic HNSCC diagnosed histologically and/or cytologically that could not be completely resected surgically and could not be treated with radical simultaneous radiotherapy, or local and or neck recurrence after radical surgery that had progressed with radiotherapy or were unsuitable for radiotherapy. Cohort 1 and 2 : Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for previous recurrent or metastatic stage and has positive PD-L1 expression (CPS ≥ 1); for subjects who have received previous adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, if disease progression occurs after the end of the last chemotherapy session ≥ 6 months, are eligible to participate in this cohort. Cohort 3: Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent, or radical radiotherapy for locally advanced disease, are eligible to participate in this cohort if disease progression occurs ≥6 months after the end of the last chemotherapy treatment. Cohort 4: Recurrent or metastatic nasopharyngeal carcinoma that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, they are eligible for this cohort if disease progression occurs ≥ 6 months after the end of the last chemotherapy treatment. Note: Subjects with recurrent or residual primary foci after radiotherapy are excluded, and subjects with adenocarcinoma or sarcoma of the nasopharynx are excluded. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Objective Response Rate (ORR) | Up to approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaozhong Chen, MD
Zhejiang Cancer Hospital
Outcome results
None listed