A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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#AntiCD47 Antibody# in advanced malignant tumors

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Treatments: Carboplatin; Fluorouracil

Criteria

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 selected advanced solid tumor.

5. Phase II:

Cohort 1 and 2 :

A. Has histologically confirmed recurrent or metastatic HNSCC who had failed only first-line platinum-containing therapy.

B. Has histologically confirmed recurrent or metastatic HNSCC with PD-L1 positive (CPS≥1) without prior systemic antitumor therapy.

Cohort 3: Has histologically confirmed recurrent or metastatic HNSCC without prior systemic antitumor therapy.

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.