Loading clinical trials...

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma

NCT03454035•UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

Detailed Description

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. Up to a maximum of 30 adult patients will be enrolled in the 5 possible dose escalation cohorts. These patients will have histologically confirmed advanced solid tumor disease refractory to standard of care therapy, or for which there is no accepted standard of care. An expansion cohort enrollment will start After RP2D of ulixertinib combined with palbociclib is defined. Then 15 patients with metastatic pancreatic cancer and 15 patients with RAS-mutant melanoma will be enrolled. Note:Pancreatic cancer expansion cohort and all solid tumor cohorts are closed to enrollment.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•2. Age ≥ 18 years at the time of consent (no upper age limit)
•3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
•4. Tumor Eligibility:
•1. Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care
•2. Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting
•3. Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:
•* 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.

Exclusion Criteria

•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
•Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1,500 /mm3 Platelets ≥ 100,000/mm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN
•\*Note: Hematology and other lab parameters that are ≤ grade 2 but still meet the criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet the criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
•9. Adequate cardiac function; left ventricular ejection fraction (LVEF) \>50% as assessed by ultrasound/echocardiography (ECHO); corrected QT interval (QTc) \<470ms
•10. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
•11. Females of childbearing potential and males must be willing to abstain from heterosexual activity\* or use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. Acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, OR use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.\] \*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
•12. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
+17 more criteria

Locations (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Key Dates

Start Date

January 30, 2018

Primary Completion Date

July 15, 2026

Completion Date

November 24, 2026

Last Updated

September 11, 2025

Enrollment

ESTIMATED participants

Conditions

Tumor, SolidPancreatic CancerMelanoma

Interventions

Ulixertinib

DRUG

Palbociclib

DRUG

Contacts

Brian Burgess

CONTACT

919-966-4432 brian_burgess@med.unc.edu

Catherine Griffin

CONTACT

919-966-4432 catherine_griffin@med.unc.edu

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE1/PHASE2

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

NCT05053971

Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer