Clinical Trials

Several clinical trials have evaluated dubermatinib (TP-0903) in early- to late-phase studies across hematologic malignancies and advanced solid tumors, including acute myeloid leukemia, chronic lymphocytic leukemia, EGFR-positive non-small cell lung cancer, colorectal carcinoma, recurrent ovarian cancer, and BRAF-mutated melanoma. Sponsored by academic investigators, cooperative research groups, and pharmaceutical companies such as Sumitomo Pharma America Inc., Ohio State University, and Beat AML, LLC, these protocols encompass completed, recruiting, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03013998 RECRUITING
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Beat AML, LLC
 2016-11 PHASE2; PHASE3
NCT02729298 COMPLETED
Advanced Solid Tumors; EGFR Positive Non-small Cell Lung Cancer; Colorectal Carcinoma; Recurrent Ovarian Carcinoma; BRAF-Mutated Melanoma
Sumitomo Pharma America, Inc.
 2016-12-14 PHASE1
NCT04518345 COMPLETED
Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia
Uma Borate
 2020-11-05 EARLY_PHASE1
NCT04518345 Completed
Acute Myeloid Leukemia|Secondary Acute Myeloid Leukemia|Therapy-Related Acute Myeloid Leukemia
Uma Borate|Sumitomo Pharma America Inc.|Ohio State University Comprehensive Cancer Center
 2020-11-05 Early Phase 1
NCT03572634 TERMINATED
Chronic Lymphocytic Leukemia; CLL; SLL; Small Lymphocytic Lymphoma
Sumitomo Pharma America, Inc.
 2019-06-10 PHASE1; PHASE2
NCT02729298 Completed
Advanced Solid Tumors|EGFR Positive Non-small Cell Lung Cancer|Colorectal Carcinoma|Recurrent Ovarian Carcinoma|BRAF-Mutated Melanoma
Sumitomo Pharma America Inc.
 2016-12-14 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Dubermatinib(TP-0903) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dubermatinib (TP-0903) functions as a potent and selective AXL receptor tyrosine kinase inhibitor with an IC50 of 27 nM, blocking downstream pro-survival signaling pathways to effectively induce apoptosis in target cells. This targeted pro-apoptotic mechanism disrupts oncogenic survival cascades, providing therapeutic relevance in the management of AXL-driven malignancies such as acute myeloid leukemia and advanced solid tumors.

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.