A Study of AK112 in Advanced Malignant Tumors

NCT05214482 | Completed Phase 1

• 1 other identifier: AK117-202
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Number of patients with Adverse Events (AEs)

  Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (5)

• 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

Study Arms (2)

Phase Ib

EXPERIMENTAL

Subjects receive AK112 plus AK117 until progression

Drug: AK112; Drug: AK117

Phase II

EXPERIMENTAL

AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;

Drug: AK112; Drug: AK117; Drug: Chemotherapy

Interventions

AK112 DRUG

IV infusion,Specified dose on specified days

Phase II; Phase Ib

AK117 DRUG

IV infusion,Specified dose on specified days

Phase II; Phase Ib

Chemotherapy DRUG

IV infusion,Specified dose on specified days

Phase II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old.
• Have a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
• 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.
• Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
• Has adequate organ function.

You may not qualify if:

• Undergone major surgery within 30 days prior to the first dose of study treatment.
• Active central nervous system (CNS) metastases.
• History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
• Active Hepatitis B or Hepatitis C.
• Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
• History of severe bleeding tendency or coagulation disorder.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jieer Ying, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: January 22, 2022
• Primary Completion: November 20, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

CN (1)