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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 : Recruiting
First Posted : November 3, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Forty Seven, Inc.

November 1, 2016
November 3, 2016
August 1, 2018
November 2016
May 2020   (Final data collection date for primary outcome measure)
  • 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
  • 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
Same as current
Complete list of historical versions of study NCT02953782 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Solid Tumors
  • Drug: Hu5F9-G4
    Hu5F9-G4 will be administered weekly.
  • Drug: Cetuximab
    Cetuximab will be administered weekly.
    Other Name: ERBITUX®
  • Experimental: Phase 1b dose escalation
    In Phase 1b, patients with advanced solid tumors will receive escalating doses of Hu5F9-G4 in combination with cetuximab.
    Interventions:
    • Drug: Hu5F9-G4
    • Drug: Cetuximab
  • Experimental: Phase 2 KRAS mutant
    In Phase 2, patients with advanced KRAS mutant colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
    Interventions:
    • Drug: Hu5F9-G4
    • Drug: Cetuximab
  • 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.
    Interventions:
    • Drug: Hu5F9-G4
    • Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
Same as current
March 2023
May 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Gani Chico, MD 650-352-4150 medical@fortyseveninc.com
Contact: David Rhodes 650-352-4150 medical@fortyseveninc.com
United States
 
 
NCT02953782
5F9004
No
Not Provided
Not Provided
Forty Seven, Inc.
Forty Seven, Inc.
Not Provided
Study Chair: Gani Chico, MD Forty Seven, Inc.
Forty Seven, Inc.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP