A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

August 9, 2022 updated by: Akeso

A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

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
      • Shanghai, China
        • Recruiting
        • Shanghai Renji Hospital
        • Contact:
          • Liwei Wang

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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Have a life expectancy of at least 3 months.
  4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
  5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
  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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ib#Dosage regimen 1#
Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression
Drug: AK117
IV infusion,Specified dose on specified days
Drug: AK104
IV infusion,Specified dose on specified days
Experimental: Phase Ib#Dosage regimen 2#
Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression
Drug: AK117
IV infusion,Specified dose on specified days
Drug: AK104
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 1#
Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression
Drug: AK117
IV infusion,Specified dose on specified days
Drug: AK104
IV infusion,Specified dose on specified days
Drug: Capecitabine tablets
Oral,Specified dose on specified days
Drug: Oxaliplatin
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 2#
Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression
Drug: AK117
IV infusion,Specified dose on specified days
Drug: AK104
IV infusion,Specified dose on specified days
Drug: Cisplatin
IV infusion,Specified dose on specified days
Drug: Paclitaxel
IV infusion,Specified dose on specified days
Drug: 5-FU
IV infusion,Specified dose on specified days
Experimental: Phase II#Cohort 3#
Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression
Drug: AK117
IV infusion,Specified dose on specified days
Drug: Paclitaxel
IV infusion,Specified dose on specified days
Drug: Irinotecan
IV infusion,Specified dose on specified days
Drug: Docetaxel
IV infusion,Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of patients with Adverse Events (AEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
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
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
Duration of Response (DoR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Maximum observed concentration (Cmax) of AK117 and AK104
Time Frame: From first dose of study drug to last dose of of study drug
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
From first dose of study drug to last dose of of study drug
Minimum observed concentration (Cmin) of AK117 and AK104 at steady state
Time Frame: From first dose of study drug to last dose of of study drug
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
From first dose of study drug to last dose of of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of study drug through 30 days after last dose of study drug
The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
From first dose of study drug through 30 days after last dose of study drug

Collaborators and Investigators

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

Sponsor

Akeso

Investigators

  • Principal Investigator: Liwei Wang, MD, RenJi Hospital

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)

July 12, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK117-204

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.

Clinical Trials on Advanced Malignant Tumors

Clinical Trials on AK117

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe