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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06194877




Registration number
NCT06194877
Ethics application status
Date submitted
22/12/2023
Date registered
8/01/2024

Titles & IDs
Public title
A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
Scientific 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
Secondary ID [1] 0 0
BGB-3245-EGFR-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Pancreatic Ductal Cancer 0 0
Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-3245
Treatment: Drugs - Panitumumab

Experimental: Part 1: Dose Finding Part - 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.

Experimental: Part 2: Dose Expansion Part, Group 1 - 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.

Experimental: Part 2: Dose Expansion Part, Group 2 - 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.


Treatment: Drugs: BGB-3245
Oral capsule

Treatment: Drugs: Panitumumab
Intravenous (IV) infusion via an infusion pump
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Part 1: Number of Participants with Adverse Events of Special Interest (AESIs)
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Part 1: Number of Participants with Interruptions to Dosing with BGB-3245
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Part 1: Number of Participants with Reductions in Dosing with BGB-3245
Timepoint [5] 0 0
Up to approximately 2 years
Primary outcome [6] 0 0
Part 1: MTD of BGB-3245
Timepoint [6] 0 0
Up to approximately 2 years
Primary outcome [7] 0 0
Part 1: RP2D of BGB-3245
Timepoint [7] 0 0
Up to approximately 2 years
Primary outcome [8] 0 0
Part 2: ORR as Assessed by Initial Investigator Review
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Part 1 and 2: Plasma Concentrations of BGB-3245 and Any Relevant Metabolites
Timepoint [1] 0 0
Day 1 of each 28 day cycle (up to approximately 2 years)
Secondary outcome [2] 0 0
Part 1: ORR as Assessed by Investigator Review using RECIST v1.1
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Part 2: ORR as Assessed by Central Review
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Part 1 and 2: Duration of Response (DoR)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Part 1 and 2: Disease Control Rate (DCR)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Part 1 and 2: Progression Free Survival (PFS)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Part 2: Number of Participants with SAEs
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Part 2: Number of Participants with TEAEs
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Part 2: Number of Participants with AESIs
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Part 2: Number of Participants with Interruptions to Dosing with BGB-3245
Timepoint [10] 0 0
Up to approximately 2 years
Secondary outcome [11] 0 0
Part 2: Number of Participants with Reductions in Dosing with BGB-3245
Timepoint [11] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
Key

1. 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.
2. 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.
3. 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.
4. Participants must provide archival tumor tissue or a fresh tumor biopsy for retrospective mutation status analysis.
5. Participants must have radiologically measurable disease as defined per RECIST v1.1 at screening.
6. Eastern Cooperative Oncology Group performance status of =1 at screening.
7. Adequate hematologic and organ function, as indicated by defined laboratory values, prior to Cycle 1 Day 1.
8. Adequate cardiac function.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
2. Active infection requiring systemic treatment at the start of the study treatment.
3. Clinically significant cardiovascular disease and / or events within 6 months of signing the informed consent form.
4. Participants with toxicities that have not recovered to Grade =1 or stabilized and those Grade 2 toxicities listed as permitted in other eligibility criteria.
5. Participants with a history of pneumonitis or interstitial lung disease.
6. Participants with immune-related toxicities that have not resolved with appropriate management.
7. History or presence of gastrointestinal disease or other condition known to interfere with the absorption of drugs.
8. History of ulcerative colitis or Crohn's disease or protracted and ongoing immune-mediated diarrhea from prior checkpoint inhibitor use.
9. History of corneal perforation, keratitis, or severe dry eye.
10. Current evidence of symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
11. 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.
12. Known hypersensitivity to rapidly accelerated fibrosarcoma (RAF) inhibitors, anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, or their excipients.
13. 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.
14. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/05/2027
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MapKure, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
MapKure
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@mapkure.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06194877