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

Akeso

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: AK112; Drug: AK117; Drug: 5-Fluorouracil; Drug: Cisplatin; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05229497

AK117-201

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#AntiCD47 Antibody# in advanced malignant tumors

Enrollment: 114 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

114 participants in 5 patient groups

Phase Ib#Dosage regimen 1#

Experimental group

Description:

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)

Treatment:

Drug: AK117

Drug: AK112

Phase Ib#Dosage regimen 2#

Experimental group

Description:

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)

Treatment:

Drug: AK117

Drug: AK112

Phase II#Cohort 1#

Experimental group

Description:

Head and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W)

Treatment:

Drug: AK112

Phase II#Cohort 2#

Experimental group

Description:

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)

Treatment:

Drug: AK117

Drug: AK112

Phase II#Cohort 3#

Experimental group

Description:

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil

Treatment:

Drug: AK117

Drug: 5-Fluorouracil

Drug: Cisplatin

Drug: Carboplatin

Drug: AK112