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

a study on Solid Tumor RAF Mutation RAS Mutation NF1 Mutation Lung Cancer Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Skin Cancer/Melanoma BRAF Gene Mutation CRAF Gene Mutation Prostate Cancer Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Rahul Aggarwal, MD (ucsf)
Headshot of Rahul Aggarwal
Rahul Aggarwal

Description

Summary

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).

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

Keywords

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), Advanced malignancies, Neoplasms, DCC-3084

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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)

Locations

  • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • University of Southern California - Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Rahul Aggarwal, MD (ucsf)
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Deciphera Pharmaceuticals, LLC
ID
NCT06287463
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated