BGB-3245 + Panitumumab 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 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 3

~7150

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