A Study of AK112 in Advanced Malignant Tumors

Last updated: March 10, 2025
Sponsor: Akeso
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

AK112

Chemotherapy

AK117

Clinical Study ID

NCT05214482
AK117-202
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 locallyadvanced,recurrent or metastatic gastric or GEJ adenocarcinoma. cohort 2 : Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic Biliary Tract Cancers, including intrahepaticcholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. cohort 3 : Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic pancreatic ductal adenocarcinoma. cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (AmericanJoint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fitfor radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamousNSCLC;Have previously received EGFR-TKI treatment and have progressed on orfollowing.

  6. Have at least one measurable lesion based on Response Evaluation Criteria in SolidTumors (RECIST) 1.1 assessed by investigator.

  7. Has adequate organ function.

Exclusion

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 thepast 2 years (i.e.,corticosteroids or immunosuppressive drugs).

  4. Active Hepatitis B or Hepatitis C.

  5. Received previous immunotherapy, including immune checkpoint inhibitors, immunecheckpoint agonists, immune cell therapy and other treatments targeting themechanism of tumor immunity.

  6. History of severe bleeding tendency or coagulation disorder.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: AK112
Phase: 1/2
Study Start date:
January 22, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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