A Study of AK112 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）With or Without Chemotherapy in Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214482
• Other study ID #: AK117-202
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 25, 2022
• Est. completion date: January 25, 2025

Study information

• Verified date: February 2024
• 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（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 25, 2025
• Est. primary completion date: August 25, 2024
• 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 advanced solid tumor.

5. Phase II:

cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma. cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma. cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following.

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
• Chemotherapy
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	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