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

Sponsor
Akeso
Study ID
NCT05235542
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Malignant Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 12, 2022
Status verified
Jun 2026
Primary completion
May 9, 2026
Completion
May 9, 2026

Study Design

Enrollment
128 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib#Dosage regimen 1#
    Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression
  • Experimental: Phase Ib#Dosage regimen 2#
    Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression
  • Experimental: Phase II#Cohort 1#
    Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression
  • Experimental: Phase II#Cohort 2#
    Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression
  • Experimental: Phase II#Cohort 3#
    Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression

Primary Outcome Measure

Number of patients with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]

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