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Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02953782
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Forty Seven, Inc.

Study Description
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Brief Summary:

This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment of certain types of colorectal cancer as well as head and neck cancer.

The major aims of the study are: (Phase 1b) to define the safety profile and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients with advanced colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Solid Tumors Drug: Hu5F9-G4 Drug: Cetuximab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer
Study Start Date : November 2016
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1b dose escalation
In Phase 1b, patients with advanced solid tumors will receive escalating doses of Hu5F9-G4 in combination with cetuximab.
 Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly.

Drug: Cetuximab
Cetuximab will be administered weekly.
Other Name: ERBITUX®
Experimental: Phase 2 KRAS mutant
In Phase 2, patients with advanced KRAS mutant colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
 Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly.

Drug: Cetuximab
Cetuximab will be administered weekly.
Other Name: ERBITUX®
Experimental: Phase 2 KRAS wild-type
In Phase 2, patients with advanced KRAS wild-type colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
 Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly.

Drug: Cetuximab
Cetuximab will be administered weekly.
Other Name: ERBITUX®


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: 28 days ]
    Dose-limiting toxicities (DLTs) (Phase 1b only) Number of participants with a DLT

  2. Objective response rate (as defined by RECIST Version 1.1) [ Time Frame: 8 weeks ]
    Phase 2: Objective response as defined by RECIST Version 1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological Diagnosis

    • Phase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
    • Phase 2:
  • KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
  • KRAS Wild Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody, such as cetuximab, panitumumab or others.
  • Adequate performance status and hematological, liver, and kidney function
  • Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Exclusion Criteria:

  • Active brain metastases
  • Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents.
  • Phase 2 only: second malignancy within the last 3 years.
  • Known active or chronic hepatitis B or C infection or HIV
  • Pregnancy or active breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953782


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90404
Stanford University
Palo Alto, California, United States, 94305-5757
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
START Midwest
Grand Rapids, Michigan, United States, 49503
United States, Pennsylvania
UPENN
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Md Anderson
Houston, Texas, United States, 77030
START Center for Cancer Care
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Forty Seven, Inc.
California Institute for Regenerative Medicine (CIRM)
Investigators
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Study Director: Chris Takimoto, MD PhD Forty Seven, Inc.
More Information
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Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02953782    
Other Study ID Numbers: 5F9004
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD data
Keywords provided by Forty Seven, Inc.:
Colorectal Neoplasms, Hu5F9-G4, CD47, cetuximab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Hu5F9-G4
Antineoplastic Agents, Immunological
Antineoplastic Agents