RecruitingPhase 1interventionalRules rewrite

Phase 1: testing DNAJB1-PRKACA Peptide Vaccine for Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))

Q: Is NCT07430202 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07430202?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07430202?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants 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).

Official registry: https://clinicaltrials.gov/study/NCT07430202 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · enrollment listed as 27

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are DNAJB1-PRKACA Peptide Vaccine, DRP-104, or Nivolumab. The registry lists allocation as na. This study wants 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).

They plan to enroll about 27 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1b Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab for Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)

Interventions: DNAJB1-PRKACA Peptide Vaccine, DRP-104, Nivolumab, Ipilimumab

Primary outcome (registry wording): Number of participants experiencing grade 3 or above drug-related toxicities

Who it is for (from inclusion criteria)

Ages 12 Years to any
Must have histologically confirmed FLC that is metastatic or unresectable
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue
Must have demonstrated radiographic progression on prior or current immunotherapy
Patients \< 18 years old must have a body weight ≥ 40 kg
ECOG (Eastern Cooperative Oncology Group) performance status of ≤2
Patients must have adequate organ and marrow function defined by study-specified laboratory tests
Patients must have adequate kidney and liver function defined by study-specified laboratory tests

Who the registry excludes

Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies
Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:
Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures
Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug
Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment
Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and/or DRP-104 and/or nivolumab and/or ipilimumab

Public study contact (from the registry)

Colleen Apostol, RN

410-614-3644

GIClinicalTrials@jhmi.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Johns Hopkins SKCCC — Baltimore, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07430202 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07430202?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07430202?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary