Solid Tumor, AdultPhase 1NCT03905148
Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors
A Phase 1 study testing Lifirafenib and mirdametinib in people with Solid Tumor, Adult, run by BeiGene at 6 sites in 2 countries.
Trial summary
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Lifirafenib and mirdametinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 May 2019to 23 Oct 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
- Able to provide informed consent
- Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place
- Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
- Part A: NSCLC, CRC, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other)
- Part B: NRAS mutated solid tumors must have a known mutation status and a histologically or cytologically confirmed advanced or refractory solid tumor. Up to 40% Melanoma and Up to 20% CRC.
- Must have archival tumor tissue or agree to tumor biopsy
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- Measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group performance status of less than or equal to 1
- Life expectancy is greater than 12 weeks of the signing of ICF.
- Adequate organ function and no transfusion within 14 days of first dose.
- Females are of non-child bearing potential or willing to use contraception.
- Males vasectomized or agree to use contraception.
Who cannot join
- Central Nervous System metastasis
- Any retinal pathology considered to be a risk factor for central serous retinopathy
- History of glaucoma
- Active parathyroid disorder or history of malignancy associated hypercalcemia
- Clinically significant cardiac disease within the past 6 months of signing ICF.
- LVEF less than 50%
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- Abnormal QT interval at Screening
- Severe uncontrolled systemic disease
- HIV
- Clinically significant active or known history of liver disease. (Hepatitis B and Hepatitis C)
- Hemorrhage or bleeding event at NCI-CTCAE v5.0 Grade 3 or higher within 28 days of first dose.
- history of or ongoing Von Willebrand disease and/or other past or present bleeding disorders
- Increased serum calcium
- Inability to swallow oral medications
- Ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks. No chemotherapy, immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
- Concomitant systemic or glucocorticoid therapy within 2 weeks
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
- Concomitant medicines that are strong CYP3A inhibitors
- History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these drugs
- Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
- Has been administered a live vaccine within 4 weeks (28 days) of initiation of study treatment. NOTE: injectable seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia4 sites
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Linear Clinical Research
Nedlands, Western Australia, 6009
The Prince of Wales Private Hospital - Specialist Medical Randwick
Randwick, New South Wales, 2031
United States2 sites
MD Anderson
Houston, Texas, 77030
University of California Los Angeles
Santa Monica, California, 90404
About this study
Official title: A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
- Conditions
- Solid Tumor, Adult
- Being tested
- Lifirafenib, mirdametinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifirafenibDrug
Also called BGB-283
RAF Dimer Inhibitor
mirdametinibDrug
Also called PD-0325901
MEK Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens. | Experimental | Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day Receives: Drug: Lifirafenib; Drug: mirdametinib |
| Part B: Expansion | Experimental | Approximately 20 participants with NRAS mutated solid tumors will be enrolled Receives: Drug: Lifirafenib; Drug: mirdametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Serious Adverse Events
Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: Approximately 2 years from date of the participants enrollment
The incidence of DLT events and treatment-emergent AEs (TEAEs)
Measured: Approximately 2 years from date of the participants enrollment
Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in participants with selected tumor types
Measured: Approximately 2 years from date of the participants enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 May 2019
- Primary completion9 Oct 2024
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Part A will consist of dose escalation and dose-finding components to establish the max tolerated dose and/or recommended Phase 2 dose Part B will investigate efficacy and further evaluate the PK, safety, and tolerability of the combination of PD-0325901 and BGB-283 (lifirafenib).
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905148
- Sponsor's protocol ID
- BGB-283/PD-0325901-AU-001
- Status last verified
- Jan 2026
- First submitted
- 3 Apr 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Desai J, Gan H, Barrow C, Jameson M, Atkinson V, Haydon A, Millward M, Begbie S, Brown M, Markman B, Patterson W, Hill A, Horvath L, Nagrial A, Richardson G, Jackson C, Friedlander M, Parente P, Tran B, Wang L, Chen Y, Tang Z, Huang W, Wu J, Zeng D, Luo L, Solomon B. Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors. J Clin Oncol. 2020 Jul 1;38(19):2140-2150. doi: 10.1200/JCO.19.02654. Epub 2020 Mar 17.
PubMed 32182156
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT03905148
- Acronym / sponsor ID
- BGB-283/PD-0325901-AU-001
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 1 May 2019 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A will consist of dose escalation and dose-finding components to establish the max tolerated dose and/or recommended Phase 2 dose Part B will investigate efficacy and further evaluate the PK, safety, and tolerability of the combination of PD-0325901 and BGB-283 (lifirafenib).
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens. | Experimental | Drug: Lifirafenib, Drug: mirdametinibCombination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day |
| Part B: Expansion | Experimental | Drug: Lifirafenib, Drug: mirdametinibApproximately 20 participants with NRAS mutated solid tumors will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to provide informed consent
- Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place
- Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
- Must have archival tumor tissue or agree to tumor biopsy
- Measurable disease per RECIST 1.1
Key exclusion criteria (22 listed)
- Central Nervous System metastasis
- Any retinal pathology considered to be a risk factor for central serous retinopathy
- History of glaucoma
- Active parathyroid disorder or history of malignancy associated hypercalcemia
- Clinically significant cardiac disease within the past 6 months of signing ICF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifirafenibAlso: BGB-283RAF Dimer Inhibitor | Drug | Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens., Part B: Expansion |
| mirdametinibAlso: PD-0325901MEK Inhibitor | Drug | Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens., Part B: Expansion |
Primary outcome
Adverse Events and Serious Adverse Events
Time frame: Approximately 2 years from date of the participants enrollment
Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
The incidence of DLT events and treatment-emergent AEs (TEAEs)
Time frame: Approximately 2 years from date of the participants enrollment
Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in participants with selected tumor types
Time frame: Approximately 2 years from date of the participants enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Results publication: PubMed 32182156Desai J, Gan H, Barrow C, Jameson M, Atkinson V, Haydon A, Millward M, Begbie S, Brown M, Markman B, Patterson W, Hill A, Horvath L, Nagrial A, Richardson G, Jackson C, Friedlander M, Parente P, Tran B, Wang L, Chen Y, Tang Z, Huang W, Wu J, Zeng D, Luo L, Solomon B. Phase I, Open-Label, Dose-Escalation/Dose-Expansion Study of Lifirafenib (BGB-283), an RAF Family Kinase Inhibitor, in Patients With Solid Tumors. J Clin Oncol. 2020 Jul 1;38(19):2140-2150. doi: 10.1200/JCO.19.02654. Epub 2020 Mar 17.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lifirafenib and mirdametinib in people with Solid Tumor, Adult, run by BeiGene at 6 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 12 inclusion and 22 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: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events and Serious Adverse Events (time frame: Approximately 2 years from date of the participants enrollment). The study lists 3 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 NCT03905148, which also lists 1 linked publication.
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 7 Jan 2026.