A Study of AK112 in Advanced Malignant Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Malignant Tumors
• Interventions: Drug: AK112; Drug: AK117; Drug: Chemotherapy

• Registration Number: NCT05214482
• 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（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study Start: 2022-01-22
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-05
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase Ib	AK112	Subjects receive AK112 plus AK117 until progression
Phase II	AK112	AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
Phase II	Chemotherapy	AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
Phase II	AK117	AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
Phase Ib	AK117	Subjects receive AK112 plus AK117 until progression

Primary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events (AEs)	Up to approximately 2 years	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Objective Response Rate (ORR)	Up to approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Up to approximately 2 years
Time to response (TTR)	Up to approximately 2 years
Overall survival (OS)	Up to approximately 2 years
Duration of Response (DOR)	Up to approximately 2 years
Progression free survival (PFS)	Up to approximately 2 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China