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

Akeso

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: Irinotecan; Drug: 5-FU; Drug: AK117; Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine tablets; Drug: Oxaliplatin; Drug: Paclitaxel; Drug: AK104

Study type: Interventional

Funder types: Industry

Identifiers

NCT05235542

AK117-204

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 5 patient groups

Phase Ib#Dosage regimen 1#

Experimental group

Description:

Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression

Treatment:

Drug: AK117

Drug: AK104

Phase Ib#Dosage regimen 2#

Experimental group

Description:

Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression

Treatment:

Drug: AK117

Drug: AK104

Phase II#Cohort 1#

Experimental group

Description:

Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine tablets

Drug: AK117

Drug: AK104

Phase II#Cohort 2#

Experimental group

Description:

Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression

Treatment:

Drug: 5-FU

Drug: Cisplatin

Drug: AK117

Drug: Paclitaxel

Drug: AK104

Phase II#Cohort 3#

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Drug: AK117

Drug: Irinotecan

Drug: Paclitaxel