Clinical Trials

Emavusertib (CA-4948) has been evaluated in multiple clinical trials across Phase I, Phase II, and Phase I/II stages targeting hematologic malignancies and solid tumors. Sponsored by industry, government, and academic institutions, these trials reflect diverse recruitment statuses, including recruiting, not yet recruiting, suspended, and terminated. Active protocols continue to evaluate the safety, pharmacokinetics, and clinical activity of orally administered emavusertib.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07107750 RECRUITING
Metastatic Biliary Tract Cancer; Metastatic Biliary Tract Carcinoma
Washington University School of Medicine
 2026-03-27 PHASE1
NCT05564390 RECRUITING
Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm; Acute Myeloid Leukemia Post Cytotoxic Therapy; Acute Myeloid Leukemia, Myelodysplasia-Related; Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2024-06-18 PHASE2
NCT05187182 RECRUITING
Gastric Cancer; Esophageal Cancer; Stomach Cancer; Esophagus Cancer; Gastroesophageal Junction Cancer
Washington University School of Medicine
 2023-06-02 PHASE1
NCT07463820 NOT_YET_RECRUITING
Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2026-06-19 PHASE2
NCT07271667 RECRUITING
Chronic Lymphocytic Leukemia; B-cell Malignancies
Curis, Inc.
 2026-04-23 PHASE2
NCT06439836 RECRUITING
Metastatic Urothelial Carcinoma; Unresectable Urothelial Carcinoma
National Cancer Institute (NCI)
 2025-05-05 PHASE1
NCT05685602 SUSPENDED
Metastatic Pancreatic Ductal Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma
National Cancer Institute (NCI)
 2023-06-12 PHASE1
NCT06696768 RECRUITING
Metastatic Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Adenocarcinoma
National Cancer Institute (NCI)
 2025-06-23 PHASE1
NCT03328078 RECRUITING
Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy; Relapsed Primary Central Nervous System Lymphoma; Refractory Primary Central Nervous System Lymphoma
Curis, Inc.
 2017-12-28 PHASE1; PHASE2
NCT05669352 SUSPENDED
Melanoma Metastatic in the Brain
University of Florida
 2025-04 PHASE1; PHASE2
NCT04278768 SUSPENDED
Acute Myelogenous Leukemia; Myelodysplastic Syndrome
Curis, Inc.
 2020-07-06 PHASE1; PHASE2
NCT05178342 TERMINATED
Myelodysplastic Syndromes; Anemia
University of Leipzig
 2022-01-01 PHASE2
NCT05178342 Terminated
Myelodysplastic Syndromes|Anemia
University of Leipzig|Curis Inc.
 2022-01-01 Phase 2
NCT04278768 Recruiting
Acute Myelogenous Leukemia|Myelodysplastic Syndrome
Curis Inc.
 2020-07-06 Phase 1|Phase 2
NCT03328078 Recruiting
Relapsed Hematologic Malignancy|Refractory Hematologic Malignancy|Relapsed Primary Central Nervous System Lymphoma|Refractory Primary Central Nervous System Lymphoma
Curis Inc.
 2017-12-28 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-04-03)

Check the Emavusertib (CA-4948) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Emavusertib selectively binds to and inhibits interleukin-1 receptor-associated kinase 4 and FMS-like tyrosine kinase 3, thereby blocking downstream oncogenic NF-κB signaling and suppressing pro-survival pathways. This targeted molecular inhibition promotes apoptosis and impairs cellular proliferation, offering clinical relevance in suppressing growth in malignancies such as acute myelogenous leukemia and myelodysplastic syndromes.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.