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Rectal CancerPhase 2NCT07580339

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

A Phase 2 study testing DCSZ11, Radiation and Capecitabine in people with Rectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
DCSZ11, Radiation and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Nov 2026to Nov 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colleen Apostal, RN contact

410-614-3644

GIClinicalTrials@jhmi.edu

United States1 site

  • Johns Hopkins SKCCC

    Baltimore, Maryland, 21231

    Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu

    Eric Christenson, MD

Other trials in United States

About this study

Official title: 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)

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
Being tested
DCSZ11, Radiation, Capecitabine, Oxaliplatin
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCSZ11Drug

    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.

  • RadiationRadiation

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

  • CapecitabineDrug

    Also called Xeloda

    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.

  • OxaliplatinDrug

    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 groups in NCT07580339
Study groupRoleWhat they receive
DCSZ11 with ChemotherapyExperimentalNot described
Receives: Drug: DCSZ11; Radiation: Radiation; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

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

    Defined using NCI CTCAE v6.0

    Measured: 12 months

Secondary outcomes (2)

  1. 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).

    Measured: 8 months

  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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2030 (estimated)
  4. Study completionNov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580339
Sponsor's protocol ID
J2652
Other IDs
IRB00536619
Status last verified
Oct 2026
First submitted
5 May 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DCSZ11, Radiation and Capecitabine in people with Rectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Colleen Apostal, RN (410-614-3644, GIClinicalTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Complete Response (compCR) Rate (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07580339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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