Experimental cancer drug DCC-3084 tested in early trial
NCT ID NCT06287463
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested an oral drug called DCC-3084, alone or with other cancer treatments, in 29 people with advanced solid tumors that have MAPK pathway mutations (like certain lung, pancreatic, or skin cancers). The study aimed to find safe doses and see if tumors shrink. However, the trial was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DCC-3084 (oral drug)
- What this could lead to
- If successful, this could point toward a new treatment option for certain advanced cancers driven by MAPK pathway mutations.
- What could go wrong
- This is a very early (Phase 1/2) trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
29 people
The number who actually took part.
- Started
-
May 2024
- Finished
-
Feb 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 * 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 Exclusion Criteria: Module A Part 2 Cohort Specific: • 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
NEXT Oncology
San Antonio, Texas, 78229, United States
-
NEXT Oncology Virginia
Fairfax, Virginia, 22031, United States
-
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
-
SCRI Florida Cancer Specialists
Orlando, Florida, 32827, United States
-
SCRI HealthONE
Denver, Colorado, 80218, United States
-
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
-
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
-
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors