Status:
TERMINATED
A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
Lead Sponsor:
MapKure, LLC
Conditions:
Colorectal Cancer
Pancreatic Ductal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 cance...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06194877
Start Date
April 18 2024
End Date
March 10 2025
Last Update
April 20 2025
Active Locations (5)
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1
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States, 91010
2
Duke Cancer Institute
Durham, North Carolina, United States, 27710
3
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, United States, 22031
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145