Advanced Solid TumorPhase 1NCT06287463
Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway
A Phase 1 study testing DCC-3084 in people with Advanced Solid Tumor and RAF Mutation, run by Deciphera Pharmaceuticals, LLC at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, RAF Mutation, RAS Mutation
- What is being tested?
- DCC-3084
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 May 2024to 13 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria
- 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
- Documented BRAF gene mutation
- Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting
Who cannot join
- General Exclusion Criteria ModA Part 1 and 2:
- Prior treatment with certain BRAF dimer inhibitors
- Female participant is pregnant or lactating
- Received any prior or concurrent medications or therapies known to be prohibited with DCC-3084 within 14 days
- Received any prior antitumor therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-3084
- Known allergy or hypersensitivity to any component of the study drug
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- Invasive malignancy within 2 years prior to the first dose of study drug other than the study indication or specific types of cancer treated with curative intent
- Have not recovered from all clinically relevant toxicities from prior therapy
- Impaired cardiac function
- History of recent thrombotic or embolic events
- Malabsorption syndrome or other illness that could affect oral absorption
- Major surgery within 28 days of the first dose of study drug
- In addition to the general exclusion criteria, participants will also be excluded based on the cohort-specific exclusion criteria
- Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
SCRI HealthONE
Denver, Colorado, 80218
NEXT Oncology Virginia
Fairfax, Virginia, 22031
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
SCRI Oncology Partners
Nashville, Tennessee, 37203
SCRI Florida Cancer Specialists
Orlando, Florida, 32827
NEXT Oncology
San Antonio, Texas, 78229
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
About this study
Official title: A Master Protocol for the Multi-Cohort, Open-Label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Antitumor Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway
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).
- Conditions
- Advanced Solid Tumor, RAF Mutation, RAS Mutation, NF1 Mutation, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
- Being tested
- DCC-3084
- Keywords
- Advanced malignancies
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC-3084Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| DCC-3084 Module A Escalation Phase (ModA Part 1) | Experimental | Participants will receive DCC-3084 in ModA Part 1, Escalation Phase. Receives: Drug: DCC-3084 |
| DCC-3084 Module A Expansion Phase (ModA Part 2) | Experimental | Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2. Receives: Drug: DCC-3084 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
DLTs reported during ModA Part 1.
Measured: Cycle 1 (28 days)
Objective Response Rate (ORR) (ModA Part 2)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Measured: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Secondary outcomes (4)
ORR (ModA Part 1)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Measured: Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Progression-Free Survival (PFS) (ModA Part 1 and 2)
PFS is the time from start of therapy to PD or death due to any cause.
Measured: Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)
Overall Survival (OS) (ModA Part 1 and 2)
OS is the time from start of therapy to death from any cause.
Measured: Start of Therapy to Death Due to Any Cause (Estimated up to 36 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)
Cmax (ModA Part 1 and 2)
Measured: Predose up to 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start14 May 2024
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Why it stopped: Trial terminated due to a business decision, not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287463
- Sponsor's protocol ID
- DCC-3084-01-001
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol for the Multi-Cohort, Open-Label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Antitumor Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway
- ClinicalTrials.gov ID
- NCT06287463
- Acronym / sponsor ID
- DCC-3084-01-001
- Conditions
- Advanced Solid Tumor, RAF Mutation, RAS Mutation, NF1 Mutation, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
- Keywords
- Advanced malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated due to a business decision, not based on any safety concerns.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCC-3084 Module A Escalation Phase (ModA Part 1) | Experimental | Drug: DCC-3084Participants will receive DCC-3084 in ModA Part 1, Escalation Phase. |
| DCC-3084 Module A Expansion Phase (ModA Part 2) | Experimental | Drug: DCC-3084Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- Prior treatment with certain BRAF dimer inhibitors
- Female participant is pregnant or lactating
- Received any prior or concurrent medications or therapies known to be prohibited with DCC-3084 within 14 days
- Received any prior antitumor therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-3084
- Known allergy or hypersensitivity to any component of the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCC-3084Administered orally | Drug | DCC-3084 Module A Escalation Phase (ModA Part 1), DCC-3084 Module A Expansion Phase (ModA Part 2) |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
Time frame: Cycle 1 (28 days)
DLTs reported during ModA Part 1.
Objective Response Rate (ORR) (ModA Part 2)
Time frame: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
4 secondary outcomes
ORR (ModA Part 1)
Time frame: Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Progression-Free Survival (PFS) (ModA Part 1 and 2)
Time frame: Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)
Overall Survival (OS) (ModA Part 1 and 2)
Time frame: Start of Therapy to Death Due to Any Cause (Estimated up to 36 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)
Time frame: Predose up to 12 hours postdose
Results and safety
The study was stopped early (reason given: Trial terminated due to a business decision, not based on any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCC-3084 in people with Advanced Solid Tumor and RAF Mutation, run by Deciphera Pharmaceuticals, LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial terminated due to a business decision, not based on any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.