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NCT07430202 · ClinicalTrials.gov registry record · Phase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Not yet
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT07430202: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT07430202 is a Phase 1 study that has not yet begun recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07430202, a Phase 1 study, has not yet begun recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).
Primary Outcome
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v6.0) will be counted only once for a given subject.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG DRP-104
- DRUG DNAJB1-PRKACA Peptide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2026-08 |
| Est. Completion | 2030-08 |
| Phase | Phase 1 |
What is known before NCT07430202 opens enrollment
NCT07430202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT07430202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07430202 about?
NCT07430202 is a clinical study titled "A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)". The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, a...
What is the current status of trial NCT07430202?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2026-08. Estimated completion is 2030-08.
What interventions are being tested in trial NCT07430202?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), DRP-104 (DRUG), DNAJB1-PRKACA Peptide Vaccine (DRUG).
Who is sponsoring clinical trial NCT07430202?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07430202's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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