Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID: NCT07580339
Phase: PHASE2
Status: Not Yet Recruiting

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Conditions

Rectal Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

DCSZ11 — DRUG
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.
Radiation — RADIATION
Patients will receive a short course of radiation (5 Gy for 5 days) two weeks after they receive their lead-in dose of DCSZ11.
Capecitabine — DRUG
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.
Oxaliplatin — DRUG
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.

Study Details

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.