OncoMatch/Clinical Trials/NCT03454035
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Is NCT03454035 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ulixertinib and Palbociclib for tumor, solid.
Treatment: Ulixertinib · Palbociclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Melanoma
Biomarker criteria
Required: NRAS G12 mutation
NRASG12/G13/Q61
Required: NRAS G13 mutation
NRASG12/G13/Q61
Required: NRAS Q61 mutation
NRASG12/G13/Q61
Required: KRAS G12 mutation
KRASG12/G13
Required: KRAS G13 mutation
KRASG12/G13
Required: HRAS G12 mutation
HRASG12/G13
Required: HRAS G13 mutation
HRASG12/G13
Required: NRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: KRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: HRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: NF1 loss-of-function mutation
subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled
Required: BRAF wild-type
subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy — metastatic
patients who have received at least one line of therapy in the metastatic setting
Must have received: anti-PD-1 therapy
disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug
Cannot have received: cancer-directed therapy
Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib
Lab requirements
Blood counts
Hemoglobin (Hgb) ≥ 9 g/dL; ANC ≥ 1,500 /mm3; Platelets ≥ 100,000/mm3
Kidney function
Creatinine ≤1.5 x ULN or Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN
Cardiac function
LVEF >50% by ECHO; QTc <470ms
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 Adequate cardiac function; left ventricular ejection fraction (LVEF) >50% as assessed by ultrasound/echocardiography (ECHO); corrected QT interval (QTc) <470ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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