Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-28 @ 6:25 PM
Study NCT ID:
NCT07107750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CA-4948 in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Phase I Trial of CA-4948 in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CA-4948 and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer.
Detailed Description:
The first part of the study will be dose escalation of CA-4948 in combination with standard of care (SOC) cisplatin, gemcitabine, and durvalumab. Once the expansion dose of CA-4948 is determined, the expansion part of the study will open. All patients will be treated with CA-4948 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 CA-4948 on study. After 8 cycles, patients will discontinue cisplatin and gemcitabine and continue maintenance CA-4948 and durvalumab.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: