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NCT06027086 · ClinicalTrials.gov registry record · Phase 1
DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
A Phase 1 study of Fibrolamellar Hepatocellular Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT06027086: Recruiting Phase 1 study of Fibrolamellar Hepatocellular Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06027086 is a Phase 1 study of Fibrolamellar Hepatocellular Carcinoma that is actively recruiting participants, 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06027086, a Phase 1 study of Fibrolamellar Hepatocellular Carcinoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab 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 Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) will be counted only once for a given subject.
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG DRP-104
Study Locations (1)
Maryland
- Johns Hopkins SKCCC - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2033-09-01 |
| Phase | Phase 1 |
What NCT06027086 shows while recruiting
NCT06027086 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 1 condition, with Fibrolamellar Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT06027086 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06027086 about?
NCT06027086 is a clinical study titled "DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)". The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab 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 ...
What is the current status of trial NCT06027086?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2024-02-12. Estimated completion is 2033-09-01.
What conditions does trial NCT06027086 study?
This clinical trial studies the following conditions: Fibrolamellar Hepatocellular Carcinoma.
What interventions are being tested in trial NCT06027086?
The interventions under investigation include: Durvalumab (DRUG), DRP-104 (DRUG).
Who is sponsoring clinical trial NCT06027086?
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 NCT06027086 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
How this trial's enrollment target compares
Where NCT06027086's enrollment target sits among peer trials
27 1464th 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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