Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Prot… (NCT06287463) | Clinical Trial Compass
TerminatedPhase 1
Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway
Stopped: Trial terminated due to a business decision, not based on any safety concerns.
United States29 participantsStarted 2024-05-14
Plain-language summary
This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General Inclusion Criteria ModA Part 1 and 2:
* Able to take oral medication
* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements
* Adequate organ function and electrolytes
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 at Screening
* Has a life expectancy of more than 6 months
* In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria
Inclusion Criteria ModA Part 1 Cohort Specific:
* Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation
* Have exhausted all available standard of care therapies that are known to provide benefit for the participant's condition, as judged by the Investigator
Inclusion Criteria ModA Part 2 Cohort Specific:
* Documented BRAF gene mutation
* Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting
Exclusion Criteria:
General Exclusion Criteria ModA Part 1 and 2:
* Prior treatment with certain BRAF dimer inhibitors
* Female participant is pregnant or lactating
* Received any pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
Timeframe: Cycle 1 (28 days)
2
Objective Response Rate (ORR) (ModA Part 2)
Timeframe: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)