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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
Must not have
Participants receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called BGB-3245 to see if it can help patients with advanced or treatment-resistant cancers by stopping the cancer cells from growing.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not currently undergoing any cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245
Phase 1b: Further review of the ORR
Phase 1b: Objective Response Rate (ORR) as assessed by the investigator
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

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
~11 spots leftby Jun 2025
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