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A Phase 2 Study to Test Effects of Using DAY101 in Children with Brain Cancer
EU CTIS ID: 2024-510691-20-00
What this study is testing
Arm 1 (Low-Grade Glioma) To evaluate the efficacy of tovorafenib as measured by the overall response rate (ORR) as determined by an independent radiology review committee (IRC) following treatment with tovorafenib in pediatric patients aged 6 months to 25 years, inclusive, with a relapsed or progressive low-grade glioma harboring a known activating BRAF alteration Arm 2 (Low-Grade Glioma Extension) To assess the safety and tolerability of tovorafenib in pediatric patients aged 6 months to 25 years, inclusive, with a relapsed or progressive low-grade glioma harboring a known or expected to be activating RAF alteration Arm 3 (Advanced Solid Tumor) To evaluate the preliminary efficacy of tovorafenib as measured by the overall response rate (ORR) as determined by the treating investigator following treatment with tovorafenib in pediatric patients aged 6 months to 25 years, inclusive, with a relapsed or progressive advanced solid tumor harboring a known or expected to be activating RAF fusion
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be age 6 months to 25 years, inclusive, with: a) Arm 1 (Low-Grade Glioma): A relapsed or progressive low-grade glioma (LGG) with a documented known activating BRAF alteration. b) Arm 2 (Low-Grade Glioma Extension): A relapsed or progressive low-grade glioma with a documented known or expected to be activating BRAF mutation or RAF fusion. c) Arm 3 (Advanced Solid Tumor): Locally advanced or metastatic solid tumor with a documented known or expected to be activating RAF fusion.
- Patients must have histopathologic verification of malignancy at either original diagnosis or relapse.
- Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression (Arm 1 and Arm 2).
- Patients must have evaluable and/or measurable disease as specified below: a) Arm 1 (Low-Grade Glioma):Must have at least one measurable lesion. b) Arm 2 (Low-Grade Glioma Extension): Must have evaluable and/or measurable disease c) Arm 3 (Advanced Solid Tumor): Must have at least one measurable lesion
- Patients must have Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50.
You likely can't join if
- Patient has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease.
- Patient has history of any major disease, other than the primary malignancy under study, that might interfere with safe protocol participation
- Patient has major surgery within 14 days (2 weeks) prior to C1D1
- Patient has clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to C1D1
- Patient is currently enrolled in any other investigational treatment study. Participation in a concurrent observational or bio-sampling study is allowed.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Singapore
- Israel
- United States
- Korea, Republic of
- Australia
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Singapore; Israel; United States; Korea, Republic of; Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.