Emavusertib with Chemoimmunotherapy for Advanced Biliary Tract Cancer
This study is testing a new combination treatment for advanced or metastatic biliary tract cancer (cancer that has spread). It combines a drug called emavusertib (CA-4948) with standard treatments: gemcitabine, cisplatin, and durvalumab. Researchers believe emavusertib might help these standard treatments work better by affecting how cancer cells survive and how the body's immune system responds. The main goal is to see how safe this combination is and to find the best dose of emavusertib. You might be able to join if you have advanced biliary tract cancer that hasn't been treated yet and is measurable. This study is looking for 48 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It will involve a dose escalation phase to find the best dose, followed by an expansion phase, and plans to enroll 48 participants.
- What's involved
- You would receive emavusertib in combination with cisplatin, gemcitabine, and durvalumab for up to 8 cycles. After 8 cycles, you would continue with emavusertib and durvalumab for maintenance.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from consent through 30 days after your last dose of study treatment, which is estimated to be 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07107750
Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~48 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:EmavusertibGemcitabineCisplatinDurvalumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over From consent through 30 days after last dose of study treatment (estimated to be 15 months)
+1 more outcome measured
Conditions
NCT07107750
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Olivia Aranha, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Eligibility criteria
Inclusion
Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. Patients whose tumor have mixed histology but predominantly (\>50%) adenocarcinoma are allowed.
Measurable defined by RECIST v1.1.
No prior systemic treatment for advanced unresectable or metastatic BTC with the following exceptions:
Neoadjuvant or adjuvant systemic therapy completed \> 6 months from planned C1D1.
Up to two prior cycles of gemcitabine/cisplatin/anti-PD1 with no evidence of disease progression is allowed
At least 18 years of age.
ECOG performance status 0, 1, or 2
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.5 K/cumm
Platelets ≥ 100 K/cumm
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome
AST(SGOT)/ALT(SGPT) ≤ 2 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN
Creatinine clearance ≥ 35 mL/min by Cockcroft-Gault
INR ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤1.5 x IULN
Creatinine phosphokinase (CPK) elevation at screening \< Grade 2 (CPK \< 2.5 x IULN).
Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start.
The effects of emavusertib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 90 days after completion of the study.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment. Use of medical marijuana is permitted.
A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of BTC in the opinion of the investigator
History of allogeneic organ or stem cell transplant.
Currently receiving any other investigational therapeutic agents. Investigational tracers related to imaging studies are allowed with a 7 day-washout.
Clinically active CNS metastasis; treated and asymptomatic metastasis allowed at the discretion of the sponsor/investigator or site PI. Radiotherapy to the brain must be completed \> 10 days prior to planned C1D1.
Chemoradiation with curative intent within 6 months prior to C1D1 of study therapy.
Palliative radiation therapy within 10 days prior to C1D1 of study therapy.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to emavusertib, gemcitabine, cisplatin, durvalumab, or other agents used in the study.
Concomitant use of drugs with a known risk of causing prolonged QTc (with exception of Zofran if needed for supportive care) and/or Torsades de Pointes or a history of risk factors for Torsades de Pointes.
Presence of interstitial lung disease or pneumonitis ≥ G2 at time of screening.
Administration of a live attenuated vaccine within 30 days prior to C1D1
QTc (Fridericia) \>470ms on screening EKG.
Gastrointestinal condition which could impair absorption of emavusertib or inability to ingest emavusertib in the opinion of the investigator.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia in the opinion of the investigator.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of C1D1.
Patients with known HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines and in line with contraindicated concomitant medications is recommended.
Participants with active, known, or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussion with the sponsor-investigator or site PI.
Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study treatment except for adrenal replacement steroid doses \> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (\< 5 days) up to 7 days prior to initiating study treatment is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.
History of grade 3 or greater rhabdomyolysis that did not completely resolve.
Patients are unwilling to adhere to the lifestyle guidance
What this trial measures
- 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 eventsFrom consent through 30 days after last dose of study treatment (estimated to be 15 months)
Graded using CTCAE version 5.0.
- Dose escalation only: To determine an expansion dose for emavusertib in combination with gemcitabine, cisplatin, and durvalumab in patients with BTC.Completion of cycle 1 (each cycle is 21 days)