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Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer

NCT07107750 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-03

No results posted yet for this study

Summary

Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor microenvironment (TME) to render chemo- and immunotherapies effective in GI malignancy. Therefore, this trial is designed to evaluate the combination of emavusertib (CA-4948) and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer (BTC).

Conditions

  • Metastatic Biliary Tract Cancer
  • Metastatic Biliary Tract Carcinoma

Interventions

DRUG

Emavusertib

Provided by Curis.

DRUG

Gemcitabine

Standard of care.

DRUG

Cisplatin

Standard of care.

BIOLOGICAL

Durvalumab

Standard of care.

Sponsors & Collaborators

  • Curis, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Olivia Aranha, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2030-06-30
Completion
2032-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107750 on ClinicalTrials.gov