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

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05229497
Collaborator
(none)
114
Enrollment
1
Location
5
Arms
21
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors
Actual Study Start Date :
May 4, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase Ib#Dosage regimen 1#

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

Drug: AK112
IV infusion,Specified dose on specified days

Drug: AK117
IV infusion,Specified dose on specified days
Experimental: Phase Ib#Dosage regimen 2#

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

Drug: AK112
IV infusion,Specified dose on specified days

Drug: AK117
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 1#

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

Drug: AK112
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 2#

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

Drug: AK112
IV infusion,Specified dose on specified days

Drug: AK117
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 3#

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

Drug: AK112
IV infusion,Specified dose on specified days

Drug: AK117
IV infusion,Specified dose on specified days

Drug: Carboplatin
IV infusion,Specified dose on specified days

Drug: Cisplatin
IV infusion,Specified dose on specified days

Drug: 5-Fluorouracil
IV infusion,Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Number of patients with Adverse Events (AEs) [Up to approximately 2 years]

    Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

  2. Number of patients experiencing dose-limiting toxicities (DLTs) [During the first 3 weeks]

  3. Objective Response Rate (ORR) [Up to approximately 2 years]

Secondary Outcome Measures

  1. Disease control rate (DCR) [Up to approximately 2 years]

  2. Duration of Response (DOR) [Up to approximately 2 years]

  3. Time to response (TTR) [Up to approximately 2 years]

  4. Progression free survival (PFS) [Up to approximately 2 years]

  5. Overall survival (OS) [Up to approximately 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 :

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

  2. 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.

  1. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.

  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Akeso

Investigators

  • Principal Investigator: Xiaozhong Chen, MD, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05229497
Other Study ID Numbers:
  • AK117-201
First Posted:
Feb 8, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Carboplatin
Fluorouracil

Study Results

No Results Posted as of May 11, 2022