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NCT07580339 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Not yet
Registry status
Phase 2
Development phase
30
Enrollment target

NCT07580339: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT07580339 is a Phase 2 study that has not yet begun recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07580339, a Phase 2 study, has not yet begun recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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.

Primary Outcome

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 evi

Interventions

  • DRUG Capecitabine
  • DRUG Oxaliplatin
  • RADIATION Radiation
  • DRUG DCSZ11

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-07
Est. Completion 2030-07
Phase Phase 2

What is known before NCT07580339 opens enrollment

NCT07580339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.

NCT07580339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07580339 about?

NCT07580339 is a clinical study titled "Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer". 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.

What is the current status of trial NCT07580339?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-07. Estimated completion is 2030-07.

What interventions are being tested in trial NCT07580339?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Radiation (RADIATION), DCSZ11 (DRUG).

Who is sponsoring clinical trial NCT07580339?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07580339's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07580339, the US trial registry maintained by the National Library of Medicine. NCT07580339 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.