Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the number of mPDAC patients free of progression at 4 months since the initiation of therapy - disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30percent decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20percent increase in sum of diameters of target
Conditions Studied
Interventions
- DRUG Balstilimab
- DRUG Botensilimab
- DRUG KRAS Vaccine with Poly-ICLC adjuvant
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-06-24 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
What NCT06411691 shows while recruiting
NCT06411691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06411691's enrollment target sits among peer trials
54 264th of 381 higher than 116 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI