Trial record 1 of 4 for:
DAY 101-102
DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors
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| ClinicalTrials.gov Identifier: NCT04985604 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2021
Last Update Posted : December 20, 2022
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Sponsor:
Day One Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
Day One Biopharmaceuticals, Inc.
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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 |
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 Phase 1b 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.
| 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 |
|---|---|
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Experimental: Arm #1
DAY101 monotherapy
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Drug: DAY101
DAY101 tablet for oral use.
Other Name: TAK580, MLN2480 |
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Experimental: Arm #2
DAY101 plus pimasertib
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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 :
- Phase 1b: Determine the safety of DAY101 in combination with other therapies [ Time Frame: Up to 48 months ]Incidence and severity of adverse events
- 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
- 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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Secondary Outcome Measures :
- 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
- 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)
- 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
- 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
- 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
- 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
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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 of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy
Substudy B-specific exclusion criterion:
- Prior receipt of any Type-II 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
| Contact: Day One Biopharmaceuticals | 650-484-0899 | clinicaltrials@dayonebio.com |
Locations
Show 19 study locations
Sponsors and Collaborators
Day One Biopharmaceuticals, Inc.
| 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: | December 20, 2022 |
| Last Verified: | December 2022 |
| 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 |