A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title:

A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229497
• Other study ID #: AK117-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 4, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: February 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

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.

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.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

Drug:
• AK112
IV infusion,Specified dose on specified days
• AK117
IV infusion,Specified dose on specified days
• Carboplatin
IV infusion,Specified dose on specified days
• Cisplatin
IV infusion,Specified dose on specified days
• 5-Fluorouracil
IV infusion,Specified dose on specified days

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Adverse Events (AEs)	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs	Up to approximately 2 years
Primary	Number of patients experiencing dose-limiting toxicities (DLTs)		During the first 3 weeks
Primary	Objective Response Rate (ORR)		Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years
Secondary	Duration of Response (DOR)		Up to approximately 2 years
Secondary	Time to response (TTR)		Up to approximately 2 years
Secondary	Progression free survival (PFS)		Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 2 years