Overview

Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

Status:
Completed
Trial end date:
2020-02-10
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forty Seven, Inc.
Gilead Sciences
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Treatments:
Cetuximab
Magrolimab
Criteria
Key Inclusion Criteria:

- Histological Diagnosis

- Phase 1b only: Advanced solid malignancy with an emphasis on colorectal cancer
(CRC), 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 fluoropyrimidine, irinotecan, and oxaliplatin based chemotherapy and who are
relapsed or refractory to at least 1 prior systemic therapy that included an
anti-epidermal growth factor receptor (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

Key Exclusion Criteria:

- Active brain metastases

- Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein
alpha (SIRPĪ±) targeting agents.

- Phase 2 only: second malignancy within the last 3 years.

- Known active or chronic hepatitis B or C infection or human immunodeficiency virus
(HIV)

- Pregnancy or active breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.