Trial record 1 of 1 for:
04985604
Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other 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 : March 29, 2024
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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, progressive, or refractory melanoma or other 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 CRAF Gene Amplification RAF1 Gene Amplification BRAF Gene Fusion BRAF Fusion CRAF Gene Fusion CRAF Fusion RAF1 Gene Fusion RAF1 Fusion Thyroid Cancer, Papillary Spitzoid Melanoma Pilocytic Astrocytoma Pilocytic Astrocytoma, Adult Non Small Cell Lung Cancer Non-Small Cell Adenocarcinoma Colorectal Cancer Pancreatic Acinar Carcinoma Spitzoid Malignant Melanoma Bladder Cancer Bladder Urothelial Carcinoma MAP Kinase Family Gene Mutation RAS Mutation RAF Mutation MEK Mutation | Drug: Tovorafenib Drug: Pimasertib | 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.
Tovorafenib will be evaluated alone or combined with a different targeted therapy in each sub-study. The Phase 1b part of each applicable 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.
(Closed to Enrollment) Substudy A will enroll patients with recurrent or progressive melanoma or other solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.
Substudy B will enroll patients with recurrent or progressive melanoma or other solid tumors with alterations in the key proteins of the MAPK pathway.
| 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
MedlinePlus related topics:
Melanoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm #1 (Closed to Enrollment)
Tovorafenib monotherapy
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Drug: Tovorafenib
Tovorafenib tablet for oral use. |
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Experimental: Arm #2
Tovorafenib plus pimasertib
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Drug: Tovorafenib
Tovorafenib tablet for oral use. Drug: Pimasertib Pimasertib capsule for oral use. |
Primary Outcome Measures :
- Phase 1b: Determine the safety of tovorafenib 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 tovorafenib in combination with other therapies [ Time Frame: Up to 48 months ]Incidence and severity of adverse events
- Phase 2: Evaluate the efficacy of tovorafenib monotherapy or in combination with other therapies [ 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 partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Secondary Outcome Measures :
- Phase 1b: Assess efficacy of tovorafenib 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 tovorafenib 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 tovorafenib 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 tovorafenib alone and in combination with other therapies [ Time Frame: Up to 48 months ]Measure plasma concentration of tovorafenib
- Phase 1b & 2: Characterize the pharmacodynamic (PD) profile of tovorafenib 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 tovorafenib 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 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
(Closed to Enrollment) Substudy A-specific inclusion criterion:
- Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.
Substudy B-specific inclusion criterion:
- Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.
Exclusion Criteria:
- Known presence of concurrent activating mutation
- Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)
(Closed to Enrollment) Substudy A-specific exclusion criterion:
- Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy
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 21 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: | March 29, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Day One Biopharmaceuticals, Inc.:
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BRAF fusion CRAF/RAF1 fusion CRAF/RAF1 amplification |
Additional relevant MeSH terms:
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Carcinoma Melanoma Astrocytoma Thyroid Cancer, Papillary Pancreatic Neoplasms Carcinoma, Acinar Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Skin Diseases Adenocarcinoma Thyroid Neoplasms Endocrine Gland Neoplasms Head and Neck Neoplasms Endocrine System Diseases Thyroid Diseases Glioma Neoplasms, Neuroepithelial Adenocarcinoma, Papillary Pancreatic Diseases |