First-in-human, Phase 1a/1b trial to investigate BGB-3245 in Patients with Advanced or Refractory Tumors

UVA Tracking #
HSR230149
Principal Investigator
Elizabeth M Gaughan
Contact
Contact Phone
Official Trial Title
A First-in-Human, Phase 1a/1b, Open-Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dime Inhibitor BGB-3245 in Patients with Advanced or Refractor Tumors
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have advanced or refractory tumors. The purpose of this study is to learn how well BGB-3245 works and collect safety information. BGB-3245 is being studied as a possible treatment for cancers that are growing quickly or have not stopped growing despite current treatment. You will be assigned to 1 of 2 groups based on your tumor status:
• Group 1: Participants with a BRAF V600 mutation whose cancer has worsened following prior recent treatment of a BRAF and/or MEK inhibitor (approximately 40 participants)
• Group 2: Participants with a BRAF Class II mutation or a BRAF infusion mutation (approximately 20 participants)

If you are assigned to receive treatment in Group 1, you will be randomly assigned (have a 50%, 1 in 2 chance like the toss of a coin) to receive either 25 mg or 40 mg daily of BGB-3245. These 2 doses are being studied in order to further determine the safety and effectiveness of the doses for managing your disease. BGB-3245 will be given as a capsule and taken orally.

If you are assigned to receive treatment in Group 2, you will receive 40 mg daily of BGB-3245.

You will be asked to be in this study for as long as you receive benefit from the study drug while tolerating the drug well, or for up to 26 months.

Study-related procedures will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/study/NCT04249843?term=NCT04249843
uvacancertrials@hscmail.mcc.virginia.edu

Compensation: You will be paid $60 per study visit. For PK draws on cycle 1 day 1, cycle 1 day 15, and cycle 2 day 1, you will also receive $100. You may also be reimbursed up to $175 per night for a hotel stay if you live more than 50 miles from the site.

Compensation

No Compensation