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Glutamine Antagonist

DRP-104 + Durvalumab for Cancer

Phase 1 & 2

Recruiting

Led By Marina Baretti, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial tests if a combo of 2 drugs can safely help treat cancer, measuring success by how well the cancer responds & patient survival.

Who is the study for?

This trial is for individuals aged 12 or older with advanced Fibrolamellar Carcinoma (FLC) that can't be removed by surgery. They must have confirmed FLC with specific genetic features, shown progression on immunotherapy, and meet certain health criteria including organ function. Participants need to provide tissue samples and use birth control.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of DRP-104 combined with Durvalumab in treating FLC. It measures tumor response rates, how long patients live without disease progression, and overall survival time after treatment.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site for DRP-104, immune-related issues due to Durvalumab such as inflammation in organs or skin rashes, fatigue, liver enzyme changes indicating liver function impact, and possible increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a specific genetic change known as DNAJB1-PRKACA fusion.

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My cancer has grown despite immunotherapy treatment.

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I am under 18 and weigh at least 40 kg.

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My organ and bone marrow functions meet the required levels.

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My kidney and liver are working well according to recent tests.

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I can take care of myself but might not be able to do heavy physical work.

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I am 12 years old or older.

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My cancer is a type called Fibrolamellar Carcinoma and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation

Objective response rate (ORR) using immune Response Evaluation Criteria for Solid Tumors (RECIST 1.1)

Secondary outcome measures

Overall survival (OS)

Progression-free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab and DRP-104Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fibrolamellar Cancer FoundationUNKNOWN

2 Previous Clinical Trials

56 Total Patients Enrolled

1 Trials studying Hepatocellular Carcinoma

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,893 Total Patients Enrolled

5 Trials studying Hepatocellular Carcinoma

306 Patients Enrolled for Hepatocellular Carcinoma

Dracen Pharmaceuticals, Inc.Industry Sponsor

1 Previous Clinical Trials

61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available positions for participants in this experiment?

"Unfortunately, according to clinicaltrials.gov this particular trial is no longer recruiting patients; its last update was on August 30th 2023. Nonetheless, presently there are 2664 other studies that require patient enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

2024. "DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027086.