OncoMatch/Clinical Trials/NCT05988918
Multicenter Trial of ESK981 in Patients With Select Solid Tumors
Is NCT05988918 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ESK981 for pancreatic adenocarcinoma.
Treatment: ESK981 — This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Neuroendocrine Tumor
Prostate Cancer
Disease stage
Metastatic disease required
Patients with histological or cytological confirmation of advanced cancer per specific cohort.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care chemotherapy
progressed or deemed intolerant of the standard of care chemotherapy regimens
Must have received: standard of care systemic therapy
progressed or deemed intolerant of at least first-line standard of care systemic therapy
Lab requirements
Blood counts
Platelet count ≥ 75,000 cells/mm3; Absolute neutrophil count ≥ 1500 cells/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine clearance CrCl ≥ 50 mL/min per Cockcroft-Gault Formula
Liver function
AST/ALT ≤ 3x ULN, or ≤ 5x ULN if liver metastasis present; Bilirubin ≤ 1.5x ULN, or ≤ 2.5 x ULN for subjects with Gilbert's syndrome; Albumin ≥ 3 g/dL
Laboratory values ≤2 weeks during screening must be: Platelet count ≥ 75,000 cells/mm3; Absolute neutrophil count ≥ 1500 cells/mm3; Hemoglobin ≥ 9 g/dL; AST/ALT ≤ 3x upper limit of normal [ULN], or (≤ 5x ULN if liver metastasis present); Bilirubin ≤ 1.5x ULN, or (≤ 2.5 x ULN for subjects with Gilbert's syndrome); Albumin ≥ 3 g/dL; Serum creatinine clearance CrCl ≥ 50 mL/min per Cockcroft-Gault Formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rogel Cancer Center · Ann Arbor, Michigan
- Barbara Ann Karmanos Cancer Institute · Detroit, Michigan
- University of Wisconsin Carbone Cancer Center · Madison, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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