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Ulixertinib and Palbociclib for Advanced Solid Tumors

This study is testing two drugs, ulixertinib and palbociclib, together for people with advanced solid tumors, including pancreatic cancer and melanoma. Researchers want to find the safest and most effective dose of these drugs when given together. Ulixertinib works by targeting ERK, and palbociclib targets CDK4/6, which are pathways that can help cancer grow. The study is looking at how long people live after treatment. You may be able to join if you are 18 or older, have a good performance status (meaning you can perform daily activities), and have advanced solid tumors that haven't responded to standard treatments or for which there are no standard treatments. Please note that enrollment for pancreatic cancer and all solid tumor cohorts is currently closed.

Study design
This is a Phase 1 interventional study with a planned enrollment of 45 participants. It is designed to find the maximum tolerated dose of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured at 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03454035

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

Recruiting
PHASE1Ages 18–99InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~45 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:UlixertinibPalbociclib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Five weeks
+1 more outcome measured

Conditions

Tumor, Solid
Pancreatic Cancer
Melanoma

Explore related trials

MelanomaPancreatic CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Stergios Moschos, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Brian Burgess
[email protected]
919-966-4432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Tumors molecular profiling genetic aberrations: NRASG12/G13/Q61, KRASG12/G13, HRASG12/G13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled.
Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.
Subjects with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint inhibitors due to requirement for immunosuppression 5. Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort 6. Life expectancy ≥ 12 weeks 7. Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment. 8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib

What this trial measures

  • Maximum Tolerated Dose (MTD)Five weeks

    MTD of ulixertinib in combination with palbociclib in patients with advanced solid tumors of ulixertinib in combination with palbociclib in patients with advanced solid tumors

  • Overall Survival6 months after treatment

    For Expansion Cohort: To estimate overall survival (OS) after treatment with the recommended phase 2 dose of ulixertinib in combination with palbociclib in an expansion cohort of patients with metastatic pancreatic cancer