Clinical trial · Interventional
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 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC)) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNAJB1-PRKACA Peptide Vaccine | Drug | — | UNRESOLVED |
| DRP-104 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A - DNAJB1-PRKACA Peptide Vaccine with poly-ICLC adjuvant, DRP-104, Nivolumab and Ipilimumab
- interventionNames
- Drug: DNAJB1-PRKACA Peptide Vaccine
- Drug: DRP-104
- Drug: Nivolumab
- Drug: Ipilimumab
Primary outcomes (2)
- measure
- Number of participants experiencing grade 3 or above drug-related toxicities
- timeFrame
- 4 years
- description
- When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v6.0) will be counted only once for a given subject.
- measure
- Objective response rate (ORR) using immune Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Age ≥ 12 years. * 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. * Must have measurable disease per RECIST 1.1 * Willingness to provide tissue and blood samples for mandatory translational research. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test. * For both Women and Men, must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * 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 not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the IND Sponsor. * 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. * History of severe hypersensitivity reaction to any monoclonal antibody. * Has an active autoimmune disease. * Prior allogeneic stem cell transplantation or organ transplantation. * Has a diagnosis of immunodeficiency. * Systemic corticosteroids at immunosuppressive doses. * Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. * Has a pulse oximetry of \<92% on room air or is on supplemental home oxygen. * Active or untreated brain metastases or leptomeningeal metastases. * Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements. * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breastfeeding. * Has a known history of Human Immunodeficiency Virus (HIV)/AIDS. * Has active hepatitis B. Patients with chronic or acute HBV infection. * Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study. * Unwilling or unable to follow the study schedule for any reason. * Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). * Evidence of clinical ascites. * Patients with QTc prolongation \> 470 ms according to Fridericia formula. * Patients receiving potent inducers of CYP 3A4/5 (including but not limited to apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin and St. John's Wort) who cannot safely discontinue drug at least 14 days prior to Cycle 1 Day 1. * Have had an allergen hyposensitization therapy within 2 weeks prior to initiation of study treatment.
References
Publications (0)
Data not yet available