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

Last updated: August 9, 2022
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT05235542
AK117-204
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 locallyadvanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamouscell carcinoma.
  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 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, immunecheckpoint agonists, immune cell therapy and other treatments targeting the mechanismof tumor immunity.
  6. History of severe bleeding tendency or coagulation disorder.

Study Design

Total Participants: 130
Study Start date:
July 12, 2022
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • Shanghai Renji Hospital

    Shanghai,
    China

    Active - Recruiting

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