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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:November 2016
End Date:March 2023
Contact:Gani Chico, MD
Email:medical@fortyseveninc.com
Phone:650-352-4150

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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.


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
We found this trial at
8
sites
San Antonio, Texas 78229
Principal Investigator: Amita Patnaik, MD
Phone: 210-593-5252
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Philip Philip, MD
Phone: 313-576-9385
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Grand Rapids, Michigan 49503
Principal Investigator: Nehal Lakhani, MDPhD
Phone: 616-954-5554
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Grand Rapids, MI
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Houston, Texas 77030
Principal Investigator: Cathy Eng, MD
Phone: 713-792-2828
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Houston, TX
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Joel R Hecht
Phone: 310-633-8400
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Johanna Bendell, MD
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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Palo Alto, California 94304
Principal Investigator: George Fisher, MD
Phone: 650-725-2839
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Palo Alto, CA
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Philadelphia, Pennsylvania 19104
Principal Investigator: Peter O'Dwyer, MD
Phone: 215-349-8246
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Philadelphia, PA
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