A Phase 1/2 Study of DCC-3116 in Patients With MAPK Pathway Mutant Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1/2, First‑in‑Human Study of DCC‑3116 as Monotherapy and in Combination with RAS/MAPK Pathway Inhibitors in Patients with Advanced or Metastatic Solid Tumors with RAS/MAPK Pathway Mutations

• IRAS ID

  1008491

• Contact name

  Clinical Trial Information

• Contact email

  clinicaltrials@deciphera.com

• Sponsor organisation

  Deciphera Pharmaceuticals LLC

• Clinicaltrials.gov Identifier

  NCT04892017

• Research summary

  This is a Phase 1/2, multicenter, open label, first in human (FIH) study of DCC-3116 as monotherapy, and in combination with trametinib, binimetinib, or sotorasib in adult patients with advanced or metastatic solid tumors with RAS/MAPK pathway mutation, which has progressed on standard therapies, or for whom conventional therapy is not considered effective or tolerable. The clinical outlook and prognosis of participants in this study is poor (median life expectancy of less than 5 years). \n\nThe study consists of 2 parts, a monotherapy dose-escalation phase (Part 1) which will enrol approximately 100 participants, and a combination dose expansion phase (Part 2) which will enrol approximately 223 participants. There will be approximately 10 sites in North America for the Dose Escalation Phase (Part 1) and approximately 70 sites globally for the Dose Expansion Phase (Part 2). The UK will participate in Part 2. The Dose Expansion Phase (Part 2) will have up to 5 expansion cohorts:\n-Expansion Cohort 1: Patients with Pancreatic ductal adenocarcinoma (PDAC) \n-Expansion Cohort 2: Patients with Non-small cell lung cancer (NSCLC) \n-Expansion Cohort 3: Patients with Colorectal cancer (CRC)\n-Expansion Cohort 4: Patients with Melanoma\n-Expansion Cohort 5: Patients with KRAS G12C mutant NSCLC\n\nIn part 2, DCC-3116 will be administered to participants orally in 28-day cycles in combination with trametinib, in combination with binimetinib, or in combination with sotorasib (Dose Expansion Cohort 1,2,3,4 and 5 respectively) according to the assigned dose and regimen. Participants may remain on treatment until they develop progressive disease as determined by the Investigator based on clinical or radiographic assessment according to RECIST v1.1, experience unacceptable toxicity, or withdraw consent.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  23/EE/0258

• Date of REC Opinion

  23 May 2024

• REC opinion

  Further Information Favourable Opinion