Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

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