A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235542
• Other study ID #: AK117-204
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 12, 2022
• Est. completion date: March 2024

Study information

• Verified date: August 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 AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2024
• Est. primary completion date: March 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 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.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

Drug:
• AK104
IV infusion,Specified dose on specified days
• AK117
IV infusion,Specified dose on specified days
• Capecitabine tablets
Oral,Specified dose on specified days
• Oxaliplatin
IV infusion,Specified dose on specified days
• Cisplatin
IV infusion,Specified dose on specified days
• Paclitaxel
IV infusion,Specified dose on specified days
• Irinotecan
IV infusion,Specified dose on specified days
• Docetaxel
IV infusion,Specified dose on specified days
• 5-FU
IV infusion,Specified dose on specified days

Locations

Country	Name	City	State
China	Shanghai Renji Hospital	Shanghai

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)		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
Secondary	Maximum observed concentration (Cmax) of AK117 and AK104	The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.	From first dose of study drug to last dose of of study drug
Secondary	Minimum observed concentration (Cmin) of AK117 and AK104 at steady state	The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.	From first dose of study drug to last dose of of study drug
Secondary	Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).	From first dose of study drug through 30 days after last dose of study drug