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OncoMatch/Clinical Trials/NCT05685602

CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer

Is NCT05685602 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Emavusertib and Gemcitabine Hydrochloride for metastatic pancreatic ductal adenocarcinoma.

Phase 1RecruitingNational Cancer Institute (NCI)NCT05685602Data as of May 2026

Treatment: Emavusertib · Gemcitabine Hydrochloride · Nab-paclitaxelThis phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). CA-4948 is in a class of medications called kinase inhibitors. It works by blocking the action of abnormal proteins called interleukin-1 receptor-associated kinase 4 (IRAK4) and FMS-like tyrosine kinase 3 (FLT3) that signal cells to multiply. This may help keep cancer cells from growing. The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage III, IV (AJCC v8)

Metastatic disease required

metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: fluorouracil-based therapy (fluorouracil, 5-FU) — metastatic or unresectable

disease progression on or after fluorouracil (5-FU)-based therapy for metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC)

Cannot have received: gemcitabine and nab-paclitaxel (gemcitabine, nab-paclitaxel)

Exception: if received as adjuvant therapy, must be >12 months from study enrollment

Prior use of gemcitabine/nab-paclitaxel for metastatic or unresectable disease is not allowed

Cannot have received: chemotherapy or radiotherapy

Exception: within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

Lab requirements

Blood counts

Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL

Kidney function

GFR >= 60 mL/min (CKD-EPI estimation)

Liver function

Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN

Cardiac function

NYHA Functional Classification class 2B or better; Prolonged QTcF (> 470 in females, > 450 in males) on screening ECG excluded

Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN; GFR >= 60 mL/min (CKD-EPI); NYHA Functional Classification class 2B or better; Prolonged QTcF (> 470 in females, > 450 in males) on screening ECG excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Comprehensive Cancer Center · Duarte, California
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
  • UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
  • UCHealth University of Colorado Hospital · Aurora, Colorado
  • Northwestern University · Chicago, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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