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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07107750
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Biliary Tract Cancer
  • Metastatic Biliary Tract Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emavusertib — DRUG
    Provided by Curis.
  • Gemcitabine — DRUG
    Standard of care.
  • Cisplatin — DRUG
    Standard of care.
  • Durvalumab — BIOLOGICAL
    Standard of care.

Study Details

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).

Key Dates

Start date
Mar 27, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
May 31, 2032

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Dose Level 0 (starting dose): Emavusertib + Gemcitabine + Cisplatin + Durvalumab
    * Treatment will be administered on a 21-day cycle. * Emavusertib will be self-administered at the assigned dose by mouth twice per day at approximately 12-hour intervals. * Cisplatin and gemcitabine will be administered intravenously on Days 1 and 8 for up to 8 total cycles as per standard of care. Up to 2 cycles of gemcitabine and cisplatin, with or without durvalumab, may be given off protocol prior to enrollment; therefore some patients may receive only 6 or 7 cycles of gemcitabine, cisplatin, and durvalumab in combination with emavusertib on study. Durvalumab will be administered IV on Day 1 of each cycle. Durvalumab will continue in combination with emavusertib as maintenance therapy starting with Cycle 9 (or earlier, if patient discontinues cisplatin and gemcitabine prior to Cycle 9).
  • Experimental: Dose Escalation Dose Level -1: Emavusertib + Gemcitabine + Cisplatin + Durvalumab
    * Treatment will be administered on a 21-day cycle. * Emavusertib will be self-administered at the assigned dose by mouth twice per day at approximately 12-hour intervals. * Cisplatin and gemcitabine will be administered intravenously on Days 1 and 8 for up to 8 total cycles as per standard of care. Up to 2 cycles of gemcitabine and cisplatin, with or without durvalumab, may be given off protocol prior to enrollment; therefore some patients may receive only 6 or 7 cycles of gemcitabine, cisplatin, and durvalumab in combination with emavusertib on study. Durvalumab will be administered IV on Day 1 of each cycle. Durvalumab will continue in combination with emavusertib as maintenance therapy starting with Cycle 9 (or earlier, if patient discontinues cisplatin and gemcitabine prior to Cycle 9).
  • Experimental: Dose Expansion: Emavusertib + Gemcitabine + Cisplatin + Durvalumab
    * Treatment will be administered on a 21-day cycle. * Emavusertib will be self-administered at the assigned dose by mouth twice per day at approximately 12-hour intervals. * Cisplatin and gemcitabine will be administered intravenously on Days 1 and 8 for up to 8 total cycles as per standard of care. Up to 2 cycles of gemcitabine and cisplatin, with or without durvalumab, may be given off protocol prior to enrollment; therefore some patients may receive only 6 or 7 cycles of gemcitabine, cisplatin, and durvalumab in combination with emavusertib on study. Durvalumab will be administered IV on Day 1 of each cycle. Durvalumab will continue in combination with emavusertib as maintenance therapy starting with Cycle 9 (or earlier, if patient discontinues cisplatin and gemcitabine prior to Cycle 9).

Primary Outcome Measure

To determine the safety of emavusertib in combination with gemcitabine, cisplatin, and durvalumab in patients with BTC as measured by incidences and types of adverse events [ Time Frame: From consent through 30 days after last dose of study treatment (estimated to be 15 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Olivia Aranha, M.D., Ph.D.
[email protected]
314-747-7509
Olivia Aranha, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Greg Fox, M.D., Ph.D. (SUB_INVESTIGATOR)
YiFei Xu, Ph.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)
Vivian Ortiz, M.D. (SUB_INVESTIGATOR)

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