Evorpacept Combinations in Advanced Solid Tumors: Phase I Results
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Phase I Trial Results
- November 29, 2021
On November 15, 2021, researchers led by Nehal J Lakhani published Phase I trial results in The Lancet, evaluating evorpacept (CD40 receptor agonist) combined with anti-PD-1 or anti-HER2 monoclonal antibodies in previously untreated advanced solid tumors unsuitable for standard therapy.
Trial Design
Patient Population: Previously untreated advanced solid tumors ineligible for standard therapy (n=110)
Treatment Arms:
- Evorpacept monotherapy 30 mg/kg (n=28)
- Evorpacept 0.3-10 mg/kg + Tislelizumab 200 mg (n=52)
- Evorpacept 0.3-10 mg/kg + Trastuzumab 6 mg/kg (n=30)
Primary Endpoints: Maximum tolerated dose, safety
Safety Results
Dose-Limiting Toxicities:
- Evorpacept alone: 7% (neutropenia, thrombocytopenia)
- Grade 3 thrombocytopenia: 4-7% across cohorts
- Grade 3 neutropenia: 7% (trastuzumab cohort)
Efficacy Results
Objective Response Rates:
- Squamous cell carcinoma (anti-PD-1): 20%
- Non-small cell lung cancer (anti-PD-1): 5%
- Gastric cancer (anti-HER2): 21.1%
Clinical Conclusions
Evorpacept combined with anti-PD-1 or anti-HER2 antibodies demonstrates acceptable safety profile in previously untreated advanced solid tumors.
Data Source
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00584-2/fulltext
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