Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanc… (NCT04249843) | Clinical Trial Compass
TerminatedPhase 1
Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors
Stopped: The study was terminated by the sponsor for reasons unrelated to safety.
United States, Australia109 participantsStarted 2020-02-17
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with histologically confirmed advanced or metastatic solid tumor who had disease progression during or after systemic anticancer therapies that previously demonstrated clinical benefit (eg, improved survival) in a representative population, or are unable to receive standard therapy(ies). In addition, participants must meet the following eligibility criteria for the corresponding phase of the study:
. Phase 1a: participants with a known mutation status and tumor harboring an oncogenic mutation of the v-RAF murine sarcoma viral oncogene homolog B (BRAF) gene (the mutations of primary interest are the BRAF Class II mutation, Class III mutation or BRAF fusion). In addition, participants with tumors harboring the mutation of the neuroblastoma RAS viral oncogene homolog (NRAS) gene or the Kirsten rat sarcoma virus oncogene homolog (KRAS) are eligible for Part 1a. For participants with KRAS mutations, tumor types of colorectal cancer (CRC) and pancreatic cancer are excluded.
. Phase 1b: participants must have a known mutation status and meet one of the following criteria according to the group they are enrolled into:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs)
Timeframe: Up to 30 days after the last dose of study drug
2
Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs)
Timeframe: Up to 30 days after the last dose of study drug
3
Phase 1a: number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
Timeframe: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
4
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245
Timeframe: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
5
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-3245
Timeframe: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
6
Phase 1b: Objective Response Rate (ORR) as assessed by the investigator
. Participants must provide archival tumor tissue or agree to a fresh tumor biopsy for mutation and biomarkers analysis (fresh tumor biopsies are strongly recommended)
. Participants must have radiologically measurable disease as defined by RECIST v1.1
. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
. Adequate organ function and no transfusions within 14 days of first dose
Exclusion criteria
. Participants receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
. All participants who have received prior systemic anticancer treatment within the following time frames will be excluded:
. Systemic chemotherapy within 4 weeks or 6 weeks for nitrosourea, mitomycin prior to Cycle 1 Day 1; and
. Biologic therapy (i.e., antibodies), continuous or intermittent small-molecule therapies, or any other investigational agents within a period of 5 times the half-life of the agent or ≤4 weeks (whichever is shorter) prior to Cycle 1 Day 1.
. Severe or uncontrolled systemic disease.
. Clinically significant cardiac disease within 6 months of signing the ICF
. CNS metastases, leptomeningeal carcinomatosis or untreated spinal cord compression.
. Any unstable, preexisting major medical condition, including known human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.