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Colorectal CancerPhase 1NCT06194877

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

A Phase 1 study testing BGB-3245 and Panitumumab in people with Colorectal Cancer and Pancreatic Ductal Cancer, run by MapKure, LLC at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objectives of Part 1 of this study are to: Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation status and tumor harboring an oncogenic mutation of v-Raf murine sarcoma viral oncogene… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-3245 and Panitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
5 sitesin 2 countries
Study dates
18 Apr 2024to 10 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically confirmed advanced or metastatic solid tumors who have had documented disease progression by RECIST criteria during or after at least 1 prior line of systemic anticancer therapies in the representative population or are unable to receive standard of care therapy(ies) as noted by local guidelines.
  • Part 1 (Dose Finding): Participants with CRC with a known mutation status by local testing and tumor harboring an oncogenic mutation of BRAF, KRAS, or NRAS in the archival tumor sample or fresh tumor biopsy.
  • Part 2 (Dose Expansion): Participants must have a known mutation status by local testing and meet one of the following criteria according to the group they are enrolled into: Group 1: Participants with CRC that harbors KRAS or NRAS mutations in the archival tumor sample or fresh tumor biopsy. Group 2: Participants with PDAC that harbors KRAS mutations in the archival tumor sample or fresh tumor biopsy.
  • Participants must provide archival tumor tissue or a fresh tumor biopsy for retrospective mutation status analysis.
  • Participants must have radiologically measurable disease as defined per RECIST v1.1 at screening.
  • Eastern Cooperative Oncology Group performance status of ≤1 at screening.
  • Adequate hematologic and organ function, as indicated by defined laboratory values, prior to Cycle 1 Day 1.
  • Adequate cardiac function.

Who cannot join

  • Participants receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
  • Active infection requiring systemic treatment at the start of the study treatment.
  • Clinically significant cardiovascular disease and / or events within 6 months of signing the informed consent form.
  • Participants with toxicities that have not recovered to Grade ≤1 or stabilized and those Grade 2 toxicities listed as permitted in other eligibility criteria.
  • Participants with a history of pneumonitis or interstitial lung disease.
  • Participants with immune-related toxicities that have not resolved with appropriate management.
Show all 15Show fewer
  • History or presence of gastrointestinal disease or other condition known to interfere with the absorption of drugs.
  • History of ulcerative colitis or Crohn's disease or protracted and ongoing immune-mediated diarrhea from prior checkpoint inhibitor use.
  • History of corneal perforation, keratitis, or severe dry eye.
  • Current evidence of symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
  • Any active malignancy ≤3 years before Cycle 1 Day 1 except for the specific cancer under investigation in this study and any localized or noninvasive cancer that has been treated curatively.
  • Known hypersensitivity to rapidly accelerated fibrosarcoma (RAF) inhibitors, anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, or their excipients.
  • Any known history of Grade ≥3 toxicity lasting >14 days from another RAF, mitogen activated protein kinase, extracellular signal-regulated kinase, or anti-EGFR antibody inhibitor requiring discontinuation of treatment from these drugs.
  • Receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer ≤14 days (or 5 half-lives, whichever is longer) before Cycle 1 Day 1 and until completion of dosing with BGB-3245 for at least 5 half-lives.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply. Summary of key criteria provided.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States3 sites

  • City of Hope Comprehensive Cancer Center - Duarte

    Duarte, California, 91010

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • USOR - Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia, 22031

Other trials in United States

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A Phase 1b, Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 With Panitumumab in Patients With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers

The primary objectives of Part 1 of this study are to:

  • Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation status and tumor harboring an oncogenic mutation of v-Raf murine sarcoma viral oncogene homolog B; B-RAF proto-oncogene, serine/threonine kinase (BRAF), Kirsten rat sarcoma viral oncogene homolog (KRAS), or neuroblastoma RAS viral oncogene homolog (NRAS) with documented disease progression during or after at least 1 line of prior therapy.
  • Determine the maximum tolerated dose (MTD) of BGB-3245 in combination with panitumumab and the recommended phase 2 dose (RP2D) of the combination.

The primary objective of Part 2 of this study is to determine the objective response rate (ORR) as assessed by initial investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with BGB-3245 and panitumumab combination treatment at the RP2D.

Being tested
BGB-3245, Panitumumab
Keywords
Advanced or Metastatic RAS mutant Colorectal and Pancreatic Ductal Cancers, BGB-3245, Panitumumab, Brimarafenib, BRAF, KRAS, NRAS
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-3245Drug

    Also called Brimarafenib

    Oral capsule

  • PanitumumabDrug

    Also called Vectibix®

    Intravenous (IV) infusion via an infusion pump

Study groups in NCT06194877
Study groupRoleWhat they receive
Part 1: Dose Finding PartExperimentalParticipants 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.
Receives: Drug: BGB-3245; Drug: Panitumumab
Part 2: Dose Expansion Part, Group 1ExperimentalParticipants 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.
Receives: Drug: BGB-3245; Drug: Panitumumab
Part 2: Dose Expansion Part, Group 2ExperimentalParticipants 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.
Receives: Drug: BGB-3245; Drug: Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Serious Adverse Events (SAEs)

    Measured: Up to approximately 2 years

  2. Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 2 years

  5. Part 1: Number of Participants with Reductions in Dosing with BGB-3245

    Measured: Up to approximately 2 years

  6. Part 1: MTD of BGB-3245

    Measured: Up to approximately 2 years

  7. Part 1: RP2D of BGB-3245

    Measured: Up to approximately 2 years

  8. Part 2: ORR as Assessed by Initial Investigator Review

    Measured: Up to approximately 2 years

Secondary outcomes (11)

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

    Measured: Day 1 of each 28 day cycle (up to approximately 2 years)

  2. Part 1: ORR as Assessed by Investigator Review using RECIST v1.1

    Measured: Up to approximately 2 years

  3. Part 2: ORR as Assessed by Central Review

    Measured: Up to approximately 2 years

  4. Part 1 and 2: Duration of Response (DoR)

    Measured: Up to approximately 2 years

  5. Part 1 and 2: Disease Control Rate (DCR)

    Measured: Up to approximately 2 years

  6. Part 1 and 2: Progression Free Survival (PFS)

    Measured: Up to approximately 2 years

  7. Part 2: Number of Participants with SAEs

    Measured: Up to approximately 2 years

  8. Part 2: Number of Participants with TEAEs

    Measured: Up to approximately 2 years

  9. Part 2: Number of Participants with AESIs

    Measured: Up to approximately 2 years

  10. Part 2: Number of Participants with Interruptions to Dosing with BGB-3245

    Measured: Up to approximately 2 years

  11. Part 2: Number of Participants with Reductions in Dosing with BGB-3245

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start18 Apr 2024
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Why it stopped: Funding terminated due to business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194877
Sponsor's protocol ID
BGB-3245-EGFR-001
Status last verified
Apr 2025
First submitted
22 Dec 2023
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-3245 and Panitumumab in people with Colorectal Cancer and Pancreatic Ductal Cancer, run by MapKure, LLC at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding terminated due to business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Serious Adverse Events (SAEs) (time frame: Up to approximately 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06194877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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