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Trial record 1 of 5 for:    forty seven inc cancer
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Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Forty Seven, Inc.
Sponsor:
Information provided by (Responsible Party):
Forty Seven, Inc.
ClinicalTrials.gov Identifier:
NCT02953782
First received: November 1, 2016
Last updated: July 28, 2017
Last verified: November 2016
  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.


Condition Intervention Phase
Colorectal Neoplasms Solid Tumors Drug: Hu5F9-G4 Drug: Cetuximab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Forty Seven, Inc.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 112
Study Start Date: November 2016
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02953782

Contacts
Contact: Chris Takimoto, MD PhD 650-352-4150 medical@fortyseveninc.com
Contact: Hassan Movahhed 650-352-4150 medical@fortyseveninc.com

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305-5757
Principal Investigator: George Fisher, MD         
United States, Michigan
Wayne State University Not yet recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Philip Philip, MD         
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathy Estkowski, BS CCRP    616-954-5554    kathy.estkowski@start.stoh.com   
Contact: Yvette C Cole, RN BSN OCN    616-954-5554    Yvette.cole@start.stoh.com   
Principal Investigator: Nehal Lakhani, MDPhD         
United States, Pennsylvania
UPENN Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Peter O'Dwyer, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell, MD    615-339-4214    asksarah@sarahcannon.com   
Contact    615-329-7274      
Principal Investigator: Johanna Bendell, MD         
United States, Texas
Md Anderson Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Cathy Eng, MD         
START Center for Cancer Care Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN MSN    210-593-5252    isabel.jimenez@start.stoh.com   
Principal Investigator: Amita Patnaik, MD         
Sponsors and Collaborators
Forty Seven, Inc.
Investigators
Study Chair: Chris Takimoto, MD PhD Forty Seven, Inc.
  More Information

Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02953782     History of Changes
Other Study ID Numbers: 5F9004
Study First Received: November 1, 2016
Last Updated: July 28, 2017

Keywords provided by Forty Seven, Inc.:
Colorectal Neoplasms, Hu5F9-G4, CD47, cetuximab

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 19, 2017