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Not Yet Recruiting
NCT07580339
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Conditions: Rectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location: Johns Hopkins SKCCC Baltimore Maryland
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 Criteria
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 \> 10 mm in size in short axis
* Evidence of extramural vascular invasion on MRI pelvis
* Absence of distant metastases on CT or MRI imaging
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
* Left ventricular ejection fraction (LVEF) assessment with documented LVEF ≥ 50% by either TTE or Multigated Acquisition (MUGA) (TTE preferred) within 6 months from first study drug administration.
* For both Women and Men, must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* 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.
* History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.
* Uncontrolled infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or Tuberculosis.
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
* Patient has a pulse oximetry of \
Source: ClinicalTrials.gov (NCT07580339). StuddyBuddy aggregates publicly available trial information.