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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985604
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
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, referred to as the MAPK pathway..

Condition or disease Intervention/treatment Phase
Melanoma Solid Tumor Drug: DAY101 Drug: Pimasertib Hydrochloride 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.

DAY101 will be evaluated alone or combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate anti-tumor activity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
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 Name: TAK580, MLN2480

Experimental: Arm #2
DAY101 plus pimasertib
Drug: DAY101
DAY101 tablet for oral use.
Other Name: TAK580, MLN2480

Drug: Pimasertib Hydrochloride
pimasertib capsule for oral use.
Other Name: pimasertib hydrochloride, AS703026, MSC1936369B




Primary Outcome Measures :
  1. Phase 1B: Determine the safety of DAY101 in combination with other therapies [ Time Frame: Up to 48 months ]
    Incidence and severity of adverse events

  2. Phase 1B: Determine the MTD and RP2D of DAY101 in combination with other therapies [ Time Frame: Up to 48 months ]
    Incidence and severity of adverse events

  3. Phase 2: Evaluate the efficacy of DAY101 monotherapy [ Time Frame: Up to 48 months ]
    Overall response rate (ORR) as assessed by the proportion of patients with the best overall confirmed response of complete response (CR) or PR according to RECIST ver 1.1


Secondary Outcome Measures :
  1. Phase 1b: Assess efficacy of DAY101 in combination with other therapies [ Time Frame: Up to 48 months ]
    Duration of response (DOR) in patients with best overall response of CR or PR

  2. Phase 1b & 2: Assess additional efficacy parameters of DAY101 alone and in combination with other therapies [ Time Frame: Up to 48 months ]
    Duration of progression-free survival (PFS) and overall survival (OS)

  3. Phase 1b & 2: Characterize tumor responses observed with DAY101 alone and in combination with other therapies [ 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

  4. Phase 1b & 2: Characterize the pharmacokinetic (PK) profile of DAY101 alone and in combination with other therapies [ Time Frame: Up to 48 months ]
    Measure plasma concentration of DAY101

  5. Phase 1b & 2: Characterize the pharmacodynamic (PD) profile of DAY101 alone and in combination with other therapies [ Time Frame: Up to 48 months ]
    Evaluate changes from baseline of phosphorylated ERK and other relevant biomarkers

  6. Phase 2: Assess the safety and tolerability of DAY101 as monotherapy, or in combination with other therapies [ Time Frame: Up to 48 months ]
    Incidence and severity of adverse events



Information from the National Library of Medicine

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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 tumor with concurrent MAPK pathway alteration as assessed by sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency
  • 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:

  • Known presence of concurrent activating mutation
  • Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)

Substudy A-specific exclusion criterion:

  • 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

Substudy B-specific exclusion criterion:

  • Prior receipt of any pan-RAF inhibitor therapy (e.g., LXH254/naporafenib, BGB- 283, BGB-3245, belvarafenib)

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 FIRELIGHT-1@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   
Hoag Health Recruiting
Newport Beach, California, United States, 92663
Contact: Wendy Price    949-764-4510    wendy.price@hoag.org   
Contact: Clinical Research Main Line    949-764-5543      
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Intake CRC       POEMSintake@cuanschutz.edu   
United States, Florida
Cancer Specialists of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mary Alice Anderson       maryalice.anderson@csnf.us   
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Janet McIntosh       jxa1221@med.miami.edu   
United States, Indiana
Community North Cancer Center Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Betsy Glowinski    317-497-2836    EGlowinski@ecommunity.com   
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   
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sarah Johnson       johnsons16@upmc.edu   
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruitment and Eligibility Office Recruiting
Nashville, Tennessee, United States, 37232
Contact    800-811-8480      
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Spain
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
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: November 4, 2022
Last Verified: November 2022

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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
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs