Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2027-08-31

Brief Summary

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This is a multicenter, Phase 1/2 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).

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Detailed Description

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Conditions

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Advanced Solid Tumor RAF Mutation RAS Mutation NF1 Mutation Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Melanoma BRAF Gene Mutation CRAF Gene Mutation Castration-Resistant Prostate Cancer (CRPC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCC-3084 Module A Escalation Phase (ModA Part 1)

Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.

Group Type EXPERIMENTAL

DCC-3084

Intervention Type DRUG

Administered orally

DCC-3084 Module A Expansion Phase (ModA Part 2)

Participants will receive DCC-3084 in ModA Part 2, Expansion Phase.

Group Type EXPERIMENTAL

DCC-3084

Intervention Type DRUG

Administered orally

Interventions

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DCC-3084

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* 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

• 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No