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A Study of AK112 in Advanced Malignant Tumors

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05214482
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
6.7
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（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel 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）With or Without Chemotherapy in Advanced Malignant Tumors
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Jan 25, 2023
Anticipated Study Completion Date :
Jan 25, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase Ib

Subjects receive AK112 plus AK117 until progression

Drug: AK112
IV infusion,Specified dose on specified days

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

AK112 + chemotherapy± AK117 until progression

Drug: AK112
IV infusion,Specified dose on specified days

Drug: AK117
IV infusion,Specified dose on specified days

Drug: Chemotherapy
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. 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 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.

  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: Jieer Ying, MD, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05214482
Other Study ID Numbers:
  • AK117-202
First Posted:
Jan 28, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 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

Study Results

No Results Posted as of Jan 28, 2022