Clinical Trials /

DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors

NCT04985604

Description:

This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04985604

Trial Eligibility

Document

Title

  • Brief Title: DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors
  • Official Title: A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

Clinical Trial IDs

  • ORG STUDY ID: DAY101-102
  • NCT ID: NCT04985604

Conditions

  • Melanoma
  • Solid Tumor

Interventions

DrugSynonymsArms
DAY101Arm #1

Purpose

This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway.

Detailed Description

      Study DAY101-102 (master study) and sub-studies will consist of a screening period, a
      treatment period, a safety follow-up period, and a long-term follow-up period where survival,
      status and subsequent anticancer therapies are collected.

      Substudy DAY101-102a is a Phase 2, multi-center, open-label sub-study of patients ≥12 years
      of age with recurrent or progressive solid tumors with activating BRAF fusion. Patients with
      these alterations will be identified through molecular assays as routinely performed at
      Clinical Laboratory Improvement Amendments of 1988 (CLIA) or other similarly certified
      laboratories. In this sub-study, patients will be enrolled either into a melanoma cohort or
      an "tissue agnostic" cohort.

Trial Arms

NameTypeDescriptionInterventions
Arm #1ExperimentalDAY101 monotherapy
  • DAY101

Eligibility Criteria

        Inclusion Criteria:

          -  Signed informed consent by patients ≥18 years of age and, assent for patients ≥ 12 up
             to < 18 years of age

          -  Patients must have a histologically confirmed diagnosis of non-hematologic tumor with
             an activating BRAF fusion

          -  Patients must have radiographically-recurrent or radiographically-progressive disease
             that is measurable using the appropriate tumor response criteria (e.g. RECIST version
             1.1)

          -  Archival tumor tissue (less than a year old) or fresh tumor tissue for correlative
             studies is required

          -  If brain metastases are present, they must have been previously treated and be stable
             as assessed by radiographic imaging

        Exclusion Criteria:

          -  Prior therapy with MEK and/or RAF inhibitors

          -  Known presence of concurrent activating mutation

          -  Patients with current evidence or a history of central serous retinopathy (CSR),
             retinal vein occlusion (RVO)
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate the efficacy of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Overall response rate (ORR) as assessed by proportion of patients with best overall confirmed response of complete response (CR) or partial response (PR) by RECIST version 1.1

Secondary Outcome Measures

Measure:Assess the safety and tolerability of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Type, incidence, and severity of treatment-emergent adverse events and laboratory abnormalities
Measure:Assess additional efficacy parameters of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Duration of response (DOR) in patients with best overall response of CR or PR
Measure:Assess additional efficacy parameters of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Duration of progression-free survival (PFS)
Measure:Characterize tumor responses observed with DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Time to response (TTR) in patients with best overall response of CR or PR; and comparing the DOR in patients with CR or PR with the DOR observed with the immediate prior line of anticancer treatment
Measure:Characterize the pharmacokinetic (PK) profile of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Measure plasma concentration of DAY101
Measure:Characterize the pharmacodynamic (PD) profile of DAY101
Time Frame:Up to 48 months
Safety Issue:
Description:Evaluate changes from baseline of phosphorylated ERK and other relevant biomarkers

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Day One Biopharmaceuticals, Inc.

Last Updated

September 1, 2021