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.
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.
Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
History of severe hypersensitivity reaction to any monoclonal antibody.
Single group
DCSZ11
DrugPatients 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
RadiationPatients will receive a short course of radiation (5 Gy for 5 days) two weeks after they receive their lead-in dose of DCSZ11.
Capecitabine
DrugPatients 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
DrugPatients 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.
Composite Complete Response (compCR) Rate
compCR is defined as the proportion of subjects with a pathologic complete response at the time of surgical resection or complete clinical response. Pathologic complete response is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0). Complete clinical response is defined as subjects with an absence of tumor on endoscopy and no evidence of metastatic disease or recurrence on imaging for 1 year from the end of treatment.
Number of participants experiencing a drug-related toxicity requiring treatment discontinuation
Defined using NCI CTCAE v6.0
Pathologic Response Rate
Pathologic response rate as defined as the proportion of subjects with complete or partial tumor regression at the time of surgery using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0 to 2).
Event-Free Survival (EFS)
EFS is defined as the number of months from the date of first dose to relapsed disease, development of metastatic disease, or death due to any cause. EFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. Estimation based on the Kaplan-Meier curve.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
DynamiCure Biotechnology
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
