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Trial record 1 of 12 for:    DAY101
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DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT04985604
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
DOT Therapeutics-1 Inc. ( Day One Biopharmaceuticals, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Solid Tumor Drug: DAY101 Phase 1 Phase 2

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 or CRAF1/RAF1 fusions or amplification. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: Arm #1
DAY101 monotherapy
Drug: DAY101
DAY101 tablet for oral use. Other names: TAK580, MLN2480




Primary Outcome Measures :
  1. Evaluate the efficacy of DAY101 [ Time Frame: Up to 48 months ]
    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 :
  1. Assess the safety and tolerability of DAY101 [ Time Frame: Up to 48 months ]
    Type, incidence, and severity of treatment-emergent adverse events and laboratory abnormalities

  2. Assess additional efficacy parameters of DAY101 [ Time Frame: Up to 48 months ]
    Duration of response (DOR) in patients with best overall response of CR or PR

  3. Assess additional efficacy parameters of DAY101 [ Time Frame: Up to 48 months ]
    Duration of progression-free survival (PFS)

  4. Characterize tumor responses observed with DAY101 [ Time Frame: Up to 48 months ]
    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

  5. Characterize the pharmacokinetic (PK) profile of DAY101 [ Time Frame: Up to 48 months ]
    Measure plasma concentration of DAY101

  6. Characterize the pharmacodynamic (PD) profile of DAY101 [ Time Frame: Up to 48 months ]
    Evaluate changes from baseline of phosphorylated ERK and other relevant biomarkers



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, CRAF/RAF1 fusion, or CRAF/RAF1 amplification.
  • 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 (preferably less than 3 years 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 BRAF-, MEK-, or MAPK-directed inhibitor therapy, except for tumor types and indications where such therapy has been approved by the FDA or applicable regulatory authorities
  • Known presence of concurrent activating mutation
  • Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985604


Contacts
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Contact: Day One Biopharmaceuticals 650-484-0899 clinical@dayonebio.com

Locations
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United States, California
The Angeles Clinic Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
United States, Florida
Cancer Specialists of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mary Alice Anderson       maryalice.anderson@csnf.us   
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Clinical Trials Information Line    503-494-1080    Phase1@ohsu.edu; trials@ohsu.edu   
Sponsors and Collaborators
Day One Biopharmaceuticals, Inc.
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Responsible Party: Day One Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04985604    
Other Study ID Numbers: DAY101-102
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas