Actively Recruiting
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-09-11
45
Participants Needed
1
Research Sites
460 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
B
BioMed Valley Discoveries, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
CONDITIONS
Official Title
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization
- Age 18 years or older
- ECOG Performance Status 0 to 2
- Histologically confirmed advanced solid tumor refractory to standard care for dose escalation groups
- Metastatic pancreatic cancer or melanoma with specific genetic mutations for expansion cohort
- At least one prior therapy for metastatic disease in expansion cohort
- Measurable or evaluable disease per RECIST v1.1
- Life expectancy of at least 12 weeks
- Recovery from prior treatment toxicities to grade 1 or baseline
- Adequate organ function including blood counts, liver and kidney function
- Adequate heart function with LVEF >50% and QTc <470ms
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception or abstinence during and after treatment
- Willingness to comply with study procedures
- Consent to provide tissue samples for research in expansion cohort
You will not qualify if you...
- Pregnant or breastfeeding
- Recent cancer treatment within 28 days prior to study drug
- History or risk of retinal vein occlusion or central serous retinopathy
- Major surgery within 28 days prior to study start
- Unwillingness to avoid certain citrus fruits during study
- Use of herbal supplements or medications affecting CYP3A4 within 7 days prior to study
- Use of drugs that strongly affect CYP3A4, CYP1A2, or CYP2D6 enzymes
- Use of drugs with narrow therapeutic index metabolized by CYP3A4
- Uncontrolled or leptomeningeal central nervous system metastases except specific melanoma cases
- Any medical condition or lab result increasing risk as judged by investigator
- Psychiatric or social issues limiting study compliance
- Active progressive additional malignancies requiring treatment
- Significant gastrointestinal issues affecting drug absorption
- Inability to swallow oral medications
- Autoimmune diseases requiring systemic corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
B
Brian Burgess
CONTACT
C
Catherine Griffin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here