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Kinase Inhibitor

Part 2: Dose Expansion Part, Group 1 for Colorectal 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

Study Summary

"This trial aims to assess the safety and effectiveness of a combination of BGB-3245 and panitumumab in patients with advanced colorectal cancer. The study will determine the maximum tolerated dose

Who is the study for?

This trial is for adults with advanced colorectal or pancreatic ductal cancers that have worsened after at least one treatment. They must be in good physical condition, have proper organ and blood function, and their tumors should have specific mutations (BRAF, KRAS, NRAS). Participants need to provide a tumor sample for analysis.Check my eligibility

What is being tested?

The study tests the combination of BGB-3245 (brimarafenib) and panitumumab on patients with certain cancer mutations. It aims to find the safest dose mix (Part 1) and then measure how well tumors respond to this combo at that dose (Part 2), using standard response criteria.See study design

What are the potential side effects?

Possible side effects include reactions related to skin, liver function changes, diarrhea, low magnesium levels typically associated with panitumumab; plus any potential but not yet known side effects from BGB-3245.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: MTD of BGB-3245

Part 1: Number of Participants with Adverse Events of Special Interest (AESIs)

Part 1: Number of Participants with Interruptions to Dosing with BGB-3245

+5 more

Secondary outcome measures

Part 1 and 2: Disease Control Rate (DCR)

Part 1 and 2: Duration of Response (DoR)

Part 1 and 2: Plasma Concentrations of BGB-3245 and Any Relevant Metabolites

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion Part, Group 2Experimental Treatment2 Interventions

Participants with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) that harbors KRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination.

Group II: Part 2: Dose Expansion Part, Group 1Experimental Treatment2 Interventions

Participants with advanced or metastatic CRC that harbors KRAS or NRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination.

Group III: Part 1: Dose Finding PartExperimental Treatment2 Interventions

Participants with advanced or metastatic CRC and with known mutation status and tumor harboring an oncogenic mutation of BRAF, KRAS, or NRAS and with documented disease progression by RECIST during or after at least 1 line of prior therapy will be enrolled into 4 planned sequentially run cohorts. Participants will receive escalating doses of BGB-3245 in combination with panitumumab to establish the MTD and RP2D by assessing the safety, tolerability, preliminary antitumor activity, and pharmacokinetics (PK) for the combination of BGB-3245 with panitumumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panitumumab

2020

Completed Phase 3

~7130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MapKure, LLCLead Sponsor

1 Previous Clinical Trials

114 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"Affirmative. Information on clinicaltrials.gov highlights the active search for participants in this study. The trial was first listed on March 29, 2024, and recently revised on March 20, 2024. A total of 64 individuals are sought after at a single designated site."

Answered by AI

What are the risks associated with Part 2: Dose Expansion Phase, Group 2 for individuals?

"Our team ranks the safety of Part 2: Dose Expansion Segment, Group 2 at a level of 1 on our scale. This rating is due to the trial being in Phase 1, signifying limited evidence backing its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers

2024. "A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06194877.