NCT07580339Not yet recruitingPhase 2
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 Hopkins1 site in 1 country30 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •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 <92% on room air.
- •Patient is on supplemental home oxygen.
- •Has clinically significant heart disease.
- •Conditions, including alcohol or drug dependence that would affect the patient's ability to comply with study visits and procedures.
- •Patient is pregnant or breastfeeding.
- •Unwilling or unable to follow the study schedule for any reason.
- •Patient received a live vaccine within 30 days of planned start of study medication.
- •Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
Arms & Interventions
DCSZ11 with Chemotherapy
Experimental
Intervention: Radiation (Radiation)
DCSZ11 with Chemotherapy
Experimental
Intervention: DCSZ11 (Drug)
DCSZ11 with Chemotherapy
Experimental
Intervention: Oxaliplatin (Drug)
DCSZ11 with Chemotherapy
Experimental
Intervention: Capecitabine (Drug)
Investigators
Study Sites (1)
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