The primary objectives of this study are: (Phase 1b) to investigate the safety and
tolerability and to determine the recommended Phase 2 dose (RP2D) for magrolimab in
combination with cetuximab; and (Phase 2) to evaluate overall response rate (ORR) of
magrolimab in combination with cetuximab in participants with Kirsten rat sarcoma 2 viral
oncogene homolog (KRAS) mutant and KRAS wild-type colorectal cancer (CRC).
- Colorectal Carcinoma
- Malignant Solid Tumor
- 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:
- NCT ID:
- Colorectal Neoplasms
- Solid Tumors
|Hu5F9-G4||Phase 1b dose escalation|
|Cetuximab||ERBITUX®||Phase 1b dose escalation|
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.
|Phase 1b dose escalation||Experimental||In Phase 1b, patients with advanced solid tumors will receive escalating doses of Hu5F9-G4 in combination with cetuximab.|
|Phase 2 KRAS mutant||Experimental||In Phase 2, patients with advanced KRAS mutant colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.|
|Phase 2 KRAS wild-type||Experimental||In Phase 2, patients with advanced KRAS wild-type colorectal cancer will receive Hu5F9-G4 in combination with cetuximab.|
- 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
- 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|
Primary Outcome Measures
|Measure:||Dose-limiting toxicities (Number of participants with a DLT)|
|Time Frame:||28 days|
|Description:||Dose-limiting toxicities (DLTs) (Phase 1b only) Number of participants with a DLT|
|Phase:||Phase 1/Phase 2|
|Lead Sponsor:||Forty Seven, Inc.|
- Colorectal Neoplasms, Hu5F9-G4, CD47, cetuximab