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 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2016
Last Update Posted : March 12, 2018
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Sponsor:
Forty Seven, Inc.
Information provided by (Responsible Party):
Forty Seven, Inc.
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 112 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 |
| Estimated Primary Completion Date : | May 2018 |
| Estimated Study Completion Date : | March 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Cetuximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Phase 1b dose escalation
In Phase 1b, patients with advanced solid tumors will receive escalating doses of Hu5F9-G4 in combination with cetuximab.
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Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly. Drug: Cetuximab Cetuximab will be administered weekly.
Other Name: ERBITUX® |
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Experimental: Phase 2 KRAS mutant
In Phase 2, patients with advanced KRAS mutant colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.
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Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly. Drug: Cetuximab Cetuximab will be administered weekly.
Other Name: ERBITUX® |
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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.
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Drug: Hu5F9-G4
Hu5F9-G4 will be administered weekly. Drug: Cetuximab Cetuximab will be administered weekly.
Other Name: ERBITUX® |
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
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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:
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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
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
Contacts
| Contact: Gani Chico, MD | 650-352-4150 | medical@fortyseveninc.com | |
| Contact: David Rhodes | 650-352-4150 | medical@fortyseveninc.com |
Locations
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90404 | |
| Contact: Msgana Tamrat 310-633-8400 mtamrat@mednet.ucla.edu | |
| Principal Investigator: Joel R Hecht | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94305-5757 | |
| Contact: Cancer Center Clinical Trials Office 650-725-2839 | |
| Principal Investigator: George Fisher, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Colette Zack 313-576-9385 zackc@karmanos.org | |
| Principal Investigator: Philip Philip, MD | |
| START Midwest | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Kathy Estkowski, BS CCRP 616-954-5554 kathy.estkowski@startmidwest.com | |
| Contact: Yvette C Cole, RN BSN OCN 616-954-5554 Yvette.cole@startmidwest.com | |
| Principal Investigator: Nehal Lakhani, MDPhD | |
| United States, Pennsylvania | |
| UPENN | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Nancy Kearny 215-349-8246 | |
| 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 | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Cathy Eng, MD 713-792-2828 CR_Study_Registration@mdanderson.org | |
| 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@startsa.com | |
| Principal Investigator: Amita Patnaik, MD | |
Sponsors and Collaborators
Forty Seven, Inc.
Investigators
| Study Chair: | Gani Chico, MD | Forty Seven, Inc. |
| Responsible Party: | Forty Seven, Inc. |
| ClinicalTrials.gov Identifier: | NCT02953782 History of Changes |
| Other Study ID Numbers: |
5F9004 |
| First Posted: | November 3, 2016 Key Record Dates |
| Last Update Posted: | March 12, 2018 |
| Last Verified: | March 2018 |
Keywords provided by Forty Seven, Inc.:
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Colorectal Neoplasms, Hu5F9-G4, CD47, cetuximab |
Additional relevant MeSH terms:
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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 |