Phase 2
Completed N=32
Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer
Source: ClinicalTrials.gov NCT02953782 ↗Enrolled (actual)
32
Serious AEs
32.1%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With Dose Limiting Toxicities (DLT) — 16.7; 0.0; 0.0; 14.3 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Dose Limiting Toxicities (DLT) |
16.7; 0.0; 0.0; 14.3; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
6.3; 0.0 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Cmax of Magrolimab |
1.04; 0.629; 0.662; 0.432; 0.517; 0.479 | — |
| SECONDARY PK Parameter: Tmax of Magrolimab |
0.10; 0.12; 0.12; 0.14; 0.13; 0.12 | — |
| SECONDARY PK Parameter: AUClast of Magrolimab |
676; 1530; 2140; 2920; 1930; 1420 | — |
| SECONDARY PK Parameter: AUCtau of Magrolimab |
676; 1630; 2140; 1930; 1640; 1560 | — |
| SECONDARY Percentage of Participants With Anti-drug Antibodies (ADA) |
0.00; 0.00; 0.00; 14.3; 0.00; 6.3 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed by RECIST v1.1 |
50.0; 38.1 | — |
| SECONDARY Duration of Response (DOR) as Assessed by RECIST v1.1 |
9.7 | — |
| SECONDARY Progression Free Survival (PFS) as Assessed by RECIST v1.1 |
3.6; 1.9 | — |
| SECONDARY Overall Survival (OS) |
9.5; 7.6 | — |
Eligibility 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 (SIRPα) 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.
Data sourced from ClinicalTrials.gov (NCT02953782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.