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

UNC Lineberger Comprehensive Cancer Center

Summary

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…

Eligibility

Age range: 18–99 years
Sex: All
Healthy volunteers: No

Detailed criteria

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 mal…

Interventions

Drug
Ulixertinib
Ulixertinib 300mg, orally, twice a day concomitantly with palbociclib
Drug
Palbociclib
Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib

Location

Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
melissa_flores@med.unc.edu