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NCT06411691 · ClinicalTrials.gov registry record · Phase 1

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

A Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Recruiting
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT06411691 is a Phase 1 study of Colorectal Cancer and Pancreatic Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 54 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06411691, a Phase 1 study of Colorectal Cancer and Pancreatic Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

RECRUITING
Registry status
Phase 1
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.

Interventions

  • DRUG Balstilimab
  • DRUG Botensilimab
  • DRUG KRAS Vaccine with Poly-ICLC adjuvant

Study Locations (1)

Maryland

  • Sidney Kimmel Comprehensive Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2025-06-24
Est. Completion 2029-07-01
Phase Phase 1

What the Registry Record Tells You About NCT06411691

The ClinicalTrials.gov registry entry for NCT06411691 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Balstilimab is the first listed.

NCT06411691 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06411691 about?

NCT06411691 is a clinical study titled "KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer". Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreat...

What is the current status of trial NCT06411691?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2025-06-24. Estimated completion is 2029-07-01.

What conditions does trial NCT06411691 study?

This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer.

What interventions are being tested in trial NCT06411691?

The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG), KRAS Vaccine with Poly-ICLC adjuvant (DRUG).

Who is sponsoring clinical trial NCT06411691?

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

Where is trial NCT06411691 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.