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

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Day One Biopharmaceuticals

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

CRAF Gene Fusion
Solid Tumor
Melanoma
CRAF Gene Amplification
Bladder Urothelial Carcinoma
Non Small Cell Lung Cancer
Pilocytic Astrocytoma, Adult
Bladder Cancer
RAF1 Gene Amplification
RAF Mutation
RAF1 Gene Fusion
MEK Mutation
BRAF Fusion
Thyroid Cancer, Papillary
Non-Small Cell Adenocarcinoma
CRAF Fusion
RAF1 Fusion
Pilocytic Astrocytoma
MAP Kinase Family Gene Mutation
Spitzoid Melanoma
BRAF Gene Fusion
Spitzoid Malignant Melanoma
RAS Mutation
Pancreatic Acinar Carcinoma
Colorectal Cancer

Treatments

Drug: Tovorafenib
Drug: Pimasertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04985604
DAY101-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

168 participants in 2 patient groups

Arm #1 (Closed to Enrollment)
Experimental group
Description:
Tovorafenib monotherapy
Treatment:
Drug: Tovorafenib
Arm #2
Experimental group
Description:
Tovorafenib plus pimasertib
Treatment:
Drug: Pimasertib
Drug: Tovorafenib

Trial contacts and locations

20

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Central trial contact

Day One Biopharmaceuticals

Data sourced from clinicaltrials.gov

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