Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Collaborator: California Institute for Regenerative Medicine (CIRM)

Stanford Investigator(s):

Intervention(s):

  • Drug: Magrolimab
  • Drug: Cetuximab

Phase:

Phase 1/Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Flordeliza Mendoza
650-724-2056
Not Recruiting