OncoMatch/Clinical Trials/NCT05733000
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
Is NCT05733000 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Devimistat and Fluorouracil for advanced biliary tract carcinoma.
Treatment: Devimistat · Fluorouracil · Gemcitabine Hydrochloride · Hydroxychloroquine — This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Ovarian Cancer
Pancreatic Cancer
Urothelial Carcinoma
Disease stage
Metastatic disease required
Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease. Patients must have radiographic documentation of metastatic disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: molecularly targeted therapy — all available
Patients must have exhausted all available molecularly targeted therapies (e.g., anti-PD-1/anti-PD-L1 agents where indicated).
Cannot have received: chemotherapy or radiotherapy (nitrosoureas, mitomycin C)
Exception: palliative radiation before and during study participation is permissible providing it is not to a target lesion
chemotherapy or radiotherapy ≤ 21 days (42 days for nitrosoureas or mitomycin C) prior to registration
Cannot have received: low dose chemotherapy concurrent with radiation
Patients receiving treatment with low dose chemotherapy concurrent with radiation ≤ 21 days prior to registration
Lab requirements
Blood counts
ANC ≥ 1,500/mcL; Hgb ≥ 9 g/dL (transfusions permitted, labs ≥ 7 days from transfusion); Platelets ≥ 100,000/mcL
Kidney function
Creatinine ≤ 1.5 x ULN OR GFR ≥ 50 mL/min/1.73 m^2 (MDRD equation)
Liver function
Total bilirubin ≤1.5 x ULN (≤2.0 mg/dL if liver metastases and no significant obstruction; Gilbert's syndrome exempt). AST/ALT ≤2.5 x ULN (≤5 x ULN if liver metastases).
Cardiac function
NYHA class 2B or better; QTcF ≤ 470 msec (female) or ≤ 450 (male); no history of congenital long QT syndrome; no symptomatic heart failure, coronary artery disease, angina, or recent MI (<90 days)
ANC ≥ 1,500/mcL; Hgb ≥ 9 g/dL; Platelets ≥ 100,000/mcL; INR ≤ 1.6 (≤ 3.0 if on anticoagulation and no active bleeding); Total bilirubin ≤1.5 x ULN (≤2.0 mg/dL if liver mets, Gilbert's exempt); AST/ALT ≤2.5 x ULN (≤5 x ULN if liver mets); Albumin > 3.0 g/dL; Creatinine ≤ 1.5 x ULN OR GFR ≥ 50 mL/min/1.73 m^2; NYHA class 2B or better; QTcF ≤ 470 msec (female) or ≤ 450 (male); no history of congenital long QT syndrome; no symptomatic heart failure, coronary artery disease, angina, or recent MI (<90 days)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
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