Combining CD93 Inhibition (DCSZ11) With Short Course Radiation and Chemotherapy as Part of Total Neoadjuvant Treatment (TNT) for High-risk Mismatch Repair Proficient (pMMR) Locally Advanced Rectal Cancer (LARC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with mismatch repair proficient (pMMR) high risk locally advanced rectal cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. * Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound. * Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma. * Must not have received any prior systemic treatment or radiation. * Patients have the following clinical staging: * cT4 any node status * Any T stage cN2 node status * Any T or N status, evidence of suspicious lateral lymph nodes…
Interventions
- DrugDCSZ11
Patients will receive a lead in dose of DCSZ11 (1200 mg administered IV). Three weeks after the lead-in dose, DCSZ11 (1200 mg administered IV) will be administered on Day 1 of each 21 day cycle for a total of 6 cycles of treatment.
- RadiationRadiation
Patients will receive a short course of radiation (5 Gy for 5 days) two weeks after they receive their lead-in dose of DCSZ11.
- DrugCapecitabine
Patients will receive Capecitabine (1000mg/m\^2 administered by mouth twice a day) will be administered on Days 1 through 14 of each 21 day cycle for a total of 6 cycles of treatment.
- DrugOxaliplatin
Patients will receive Oxaliplatin (130mg/m\^2 administered IV) will be administered on Day 1 of each 21 day cycle for a total of 6 cycles of treatment.
Location
- Johns Hopkins SKCCCBaltimore, Maryland