A Study of AK112 in Advanced Malignant Tumors

Akeso

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: Chemotherapy; Drug: AK112; Drug: AK117

Study type: Interventional

Funder types: Industry

Identifiers

NCT05214482

AK117-202

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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.

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: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Phase Ib

Experimental group

Description:

Subjects receive AK112 plus AK117 until progression

Treatment:

Drug: AK117

Drug: AK112

Phase II

Experimental group

Description:

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

Treatment:

Drug: AK117

Drug: AK112

Drug: Chemotherapy