NCT07107750

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The first part of the study will be dose escalation of emavusertib in combination with standard of care (SOC) cisplatin, gemcitabine, and durvalumab. Once the expansion dose of emavusertib is determined, the expansion part of the study will open. All patients will be treated with emavusertib in combination with SOC cisplatin, gemcitabine, and durvalumab for up to 8 total cycles. Patients may receive no more than 8 total cycles of gemcitabine and cisplatin for BTC. Up to 2 cycles of gemcitabine and cisplatin, with or without durvalumab, may be given off protocol prior to enrollment; therefore, some patients may only receive 6 or 7 cycles of gemcitabine, cisplatin, and durvalumab in combination with emavusertib on study. After 8 cycles, patients will discontinue cisplatin and gemcitabine and continue maintenance emavusertib and durvalumab.

Conditions

• Metastatic Biliary Tract Cancer
• Metastatic Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	Emavusertib	Provided by Curis.
DRUG	Gemcitabine	Standard of care.
DRUG	Cisplatin	Standard of care.
BIOLOGICAL	Durvalumab	Standard of care.

Timeline

• Start date: 2026-03-27
• Primary completion: 2030-06-30
• Completion: 2032-05-31
• First posted: 2025-08-06
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study