A Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
EU CTIS ID: 2024-516476-15-00
What this study is testing
Part 2 (Expansion): To evaluate the objective response rate of combination therapy at recommended dose(s) in each expansion cohort using histology-specific consensus response criteria.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥18 years of age
- Pathologically confirmed GIST with documented mutation in KIT exon 11.
- Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST.
- Measurable disease.
- Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1.
- Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening.
You likely can't join if
- Must not have received the following within the specified time periods prior to the first dose of study drug: 1.Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer). 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter). 3.Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days. 4.Grapefruit or grapefruit juice: 14 days.
- Have not recovered from all clinically relevant toxicities from prior therapy.
- New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug.
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease.
- Malabsorption syndrome.
- Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug.
See the full eligibility criteria
- Male or female ≥18 years of age
- Pathologically confirmed GIST with documented mutation in KIT exon 11.
- Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST.
- Measurable disease.
- Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1.
- Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening.
- Must provide a fresh tumor biopsy.
- Must not have received the following within the specified time periods prior to the first dose of study drug: 1.Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer). 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter). 3.Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days. 4.Grapefruit or grapefruit juice: 14 days.
- Have not recovered from all clinically relevant toxicities from prior therapy.
- New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug.
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease.
- Malabsorption syndrome.
- Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug.
- Major surgery within 4 weeks of the first dose of study drug.
- Active HIV, Hepatitis B or Hepatitis C infection.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.