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Brief Title: Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors

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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

INTRODUCTION

  • Org Study ID: DAY101-102
  • Secondary ID: N/A
  • NCT ID: NCT04985604
  • Sponsor: 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, 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.

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.

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.

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    July 15, 2021
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1b: Determine the safety of tovorafenib in combination with other therapies

Primary Outcome 1 - Timeframe: Up to 48 months

Primary Outcome 2 - Measure: Phase 1b: Determine the MTD and RP2D of tovorafenib in combination with other therapies

Primary Outcome 2 - Timeframe: Up to 48 months

Primary Outcome 3 - Measure: Phase 2: Evaluate the efficacy of tovorafenib monotherapy or in combination with other therapies

Primary Outcome 3 - Timeframe: Up to 48 months

CONDITION

  • 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

ELIGIBILITY

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
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)
Substudy A-specific exclusion criterion:
* Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy

Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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