Clinical Trials /

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

NCT02953782

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer
  • Official Title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 5F9004
  • NCT ID: NCT02953782

Conditions

  • Colorectal Neoplasms
  • Solid Tumors

Interventions

DrugSynonymsArms
Hu5F9-G4Phase 1b dose escalation
CetuximabERBITUX®Phase 1b dose escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Phase 1b dose escalationExperimentalIn Phase 1b, patients with advanced solid tumors will receive escalating doses of Hu5F9-G4 in combination with cetuximab.
  • Hu5F9-G4
  • Cetuximab
Phase 2 KRAS mutantExperimentalIn Phase 2, patients with advanced KRAS mutant colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
  • Hu5F9-G4
  • Cetuximab
Phase 2 KRAS wild-typeExperimentalIn Phase 2, patients with advanced KRAS wild-type colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
  • Hu5F9-G4
  • Cetuximab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities (Number of participants with a DLT)
Time Frame:28 days
Safety Issue:
Description:Dose-limiting toxicities (DLTs) (Phase 1b only) Number of participants with a DLT

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Forty Seven, Inc.

Trial Keywords

  • Colorectal Neoplasms, Hu5F9-G4, CD47, cetuximab

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