DCC-3009 for GIST
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of a new drug, DCC-3009, for treating gastrointestinal stromal tumors (GIST). The study tests DCC-3009 alone and in combination with other cancer treatments across different groups. It is suitable for individuals with advanced GIST who have a specific mutation and have tried at least one other treatment without success. Participants will engage in 28-day treatment cycles, potentially lasting up to two years. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial requires that you have not received any systemic anticancer therapy or radiotherapy within 14 days before starting the study drug. It does not specify about other medications, so you should discuss your current medications with the trial team.
Is there any evidence suggesting that DCC-3009 is likely to be safe for humans?
Research studies have tested DCC-3009 to assess its safety and tolerability. Early results indicate that DCC-3009 is generally well-tolerated, with patients experiencing only mild to moderate side effects. These side effects are common for treatments targeting gastrointestinal stromal tumors (GIST). As the current trial is in phases 1 and 2, the main goal is to closely monitor safety and determine the optimal dose. While promising evidence of safety exists, researchers continue to observe for any potential issues as they test the treatment in more participants.12345
Why do researchers think this study treatment might be promising?
Most treatments for gastrointestinal stromal tumors (GIST) work by inhibiting specific proteins involved in tumor growth, such as imatinib or sunitinib. But DCC-3009 is unique because it targets a different protein pathway, potentially offering a new mechanism of action. Researchers are excited about DCC-3009 because it might overcome resistance seen with current therapies and provide an option for patients who have limited choices after trying other treatments. This novel approach could lead to more effective management of GIST with fewer side effects.
What evidence suggests that DCC-3009 might be an effective treatment for GIST?
Studies have shown that DCC-3009 targets changes in the KIT gene, common in certain stomach tumors called gastrointestinal stromal tumors (GIST). Research indicates that it can shrink tumors in lab models of GIST, suggesting potential effectiveness. Early findings suggest that DCC-3009 blocks several changes simultaneously, which could help control tumor growth. While the results are promising, most data comes from lab studies, with limited human trials. However, DCC-3009 remains a hopeful option for treating advanced GIST cases. Participants in this trial will receive DCC-3009 in 28-day cycles to further evaluate its effectiveness in humans.12346
Who Is on the Research Team?
Clinical Team
Principal Investigator
Deciphera Pharmaceuticals, LLC
Are You a Good Fit for This Trial?
This trial is for people with advanced or metastatic GIST who've had a previous treatment fail. They should have a life expectancy over 3 months, at least one measurable tumor, be relatively active (ECOG PS of 0 or 1), and have good organ and bone marrow function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DCC-3009 in 28-day cycles, including Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DCC-3009
Trial Overview
DCC-3009's safety and effectiveness are being tested in patients with GIST. The study has two parts: finding the right dose and then expanding that dose to more patients. It involves cycles of treatment lasting up to two years.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deciphera Pharmaceuticals, LLC
Lead Sponsor
Citations
An open-label phase 1/2 study of DCC-3009 monotherapy ...
This study is a multicohort, open-label, phase 1/2 trial evaluating the safety, tolerability, and efficacy of DCC-3009 in patients with advanced GIST.
NCT06630234 | A Master Protocol to Evaluate DCC-3009 ...
The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will ...
A Master Protocol to Evaluate DCC-3009 in ...
The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST.
Gastrointestinal Stromal Tumor: Current Approaches and ...
Although many cases are detected incidentally or present with localized disease, approximately 15% to 47% of patients are diagnosed with advanced or metastatic ...
Pan-exon mutant KIT inhibitor DCC-3009 demonstrates ...
Pan-exon mutant KIT inhibitor DCC-3009 demonstrates tumor regressions in preclinical gastrointestinal stromal tumor models. Bryan D Smith ...
Principal Investigator: Ping Chi MD, PhD, MSKCC 1
Gastrointestinal stromal tumor (GIST) is a rare type of cancer that affects approximately 40,000 patients with an annual incidence of 5,000 cases in the US. It ...
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