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

NCT07580339 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: J2652IRB00536619
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• Number of participants experiencing a drug-related toxicity requiring treatment discontinuation

  Defined using NCI CTCAE v6.0

  12 months

Secondary Outcomes (2)

• Pathologic Response Rate

  8 months

• Event-Free Survival (EFS)

  24 months

Study Arms (1)

DCSZ11 with Chemotherapy

EXPERIMENTAL

Drug: DCSZ11; Radiation: Radiation; Drug: Capecitabine; Drug: Oxaliplatin

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.

DCSZ11 with Chemotherapy

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.

DCSZ11 with Chemotherapy

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.

Also known as: Xeloda

DCSZ11 with Chemotherapy

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.

DCSZ11 with Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• DynamiCure Biotechnology: collaborator

Study Sites (1)

Johns Hopkins SKCCC

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiation; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Eric Christenson, MD

  Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Apostal, RN

CONTACT

410-614-3644; GIClinicalTrials@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)