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

May 10, 2022 updated by: Akeso

A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Cisplatin
IV infusion,Specified dose on specified days
Drug: Carboplatin
IV infusion,Specified dose on specified days
Drug: 5-Fluorouracil
IV infusion,Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Adverse Events (AEs)
Time Frame: Up to approximately 2 years
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Up to approximately 2 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of patients experiencing dose-limiting toxicities (DLTs)
Time Frame: During the first 3 weeks
During the first 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Disease control rate (DCR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to response (TTR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression free survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (ACTUAL)

February 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK117-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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