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BGB-3245 for Solid Cancer

Phase 1

Recruiting

Research Sponsored by MapKure, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IV. Group 4: Patients with cutaneous melanoma harboring an NRAS mutation who consent to paired fresh biopsies.

III. Group 3: Patients with cutaneous melanoma harboring a neuroblastoma RAS viral oncogene homolog (NRAS) mutation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, BGB-3245, for treating people with advanced or refractory solid tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened after treatment or lack treatment options. They must have specific mutations in the BRAF, NRAS, or KRAS genes and can't be undergoing cancer therapy at the start. Those with certain medical conditions like HIV or active hepatitis, gastrointestinal issues affecting drug absorption, or symptomatic brain metastases are excluded.Check my eligibility

What is being tested?

The study tests BGB-3245's safety and effectiveness against advanced solid tumors with particular genetic mutations. It has two phases: Phase 1a includes various tumor types and mutations; Phase 1b focuses on four groups based on mutation type and cancer kind.See study design

What are the potential side effects?

While not specified here, side effects of BGB-3245 may include typical reactions to anticancer medications such as nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have skin cancer with an NRAS mutation and agree to provide fresh tissue samples.

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My skin cancer has an NRAS mutation.

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My non-CRC cancer has a BRAF V600 mutation and has worsened despite previous BRAF/MEK inhibitor treatments.

Select...

My advanced cancer has a specific BRAF mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245

Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs)

Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs)

+3 more

Secondary outcome measures

Phase 1a: Apparent Volume of Distribution (Vz/F) of BGB-3245

Phase 1a: Area Under the Concentration-Time Curve of 0-infinity Days (AUC0-inf) of BGB-3245

Phase 1a: Best Overall Response (BOR) as Assessed by the Investigator

+24 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b, Group 1: Dose ExpansionExperimental Treatment1 Intervention

BGB-3245 administered orally (PO)

Group II: Phase 1a: Dose EscalationExperimental Treatment1 Intervention

BGB-3245 administered orally (PO)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MapKure, LLCLead Sponsor

1 Previous Clinical Trials

64 Total Patients Enrolled

Brandon Beagle, MDStudy DirectorBeiGene

Media Library

BGB-3245 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04249843 — Phase 1

Solid Tumors Research Study Groups: Phase 1a: Dose Escalation, Phase 1b, Group 1: Dose Expansion

Solid Tumors Clinical Trial 2023: BGB-3245 Highlights & Side Effects. Trial Name: NCT04249843 — Phase 1

BGB-3245 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249843 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of risk is associated with using BGB-3245?

"Our evaluation of BGB-3245's safety at Power renders it a score of 1 since this is an initial phase trial and thus lacks sufficient evidence to support its efficacy."

Answered by AI

Could you provide an estimate of the total participants involved in this clinical trial?

"To conduct the trial, a total of 168 individuals that meet the eligibility criteria need to be recruited. MapKure, LLC will take charge of this study at Memorial Sloan Kettering Cancer Center in New york and Massachusetts General Hospital in Boston."

Answered by AI

Is the recruitment phase of this research endeavor still open to participants?

"Affirmative. The clinical trial is actively enrolling patients, as indicated on the clinicaltrials.gov website. It was first posted on February 17th 2020 and most recently modified October 25th 2022; it seeks to recruit 168 participants from 3 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors

2020. "Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04249843.