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Experimental cancer drug DCC-3084 tested in early trial

NCT ID NCT06287463

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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)

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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.