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NCT03572634
Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
Phase 1, PHASE2 trial testing TP-0903 in Chronic Lymphocytic Leukemia in 3 participants. Terminated before completion.
21 January 2020
Quick facts
| Lead sponsor | Sumitomo Pharma America, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 10 June 2019 |
| Primary completion | 21 January 2020 |
| Estimated completion | 21 January 2020 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- TP-0903 — full drug profile →
- TP-0903 and ibrutinib combination therapy
Conditions studied
- Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
- CLL — all drugs for CLL →
- SLL — all drugs for SLL →
- Small Lymphocytic Lymphoma — all drugs for Small Lymphocytic Lymphoma →
Sponsor
Sumitomo Pharma America, Inc. — full company profile →
Who can join
18 and older, any sex, with Chronic Lymphocytic Leukemia or CLL. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) were defined as all AEs that begin on or after the date of first dose of study drug. All patients in the study participated in Phase 1; a 30 day follow-up visit as part of the protocol noted patients undergo a safety evaluation in which the patient's condition during the 30 days after the last dose of study drug can be assessed. There is a visit window of up to 14 days after completion of 30 days from the last dose (ie, within 45 days after last dose).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (4 terms)
| Reaction | System | TP-0903 Monotherapy (25mg … | TP-0903 and Ibrutinib Comb… |
|---|---|---|---|
| Lung Infection | Infections and infestations | — | — |
| Increased Alanine Aminotransferase and Aspartate Aminotransferase levels | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
Other adverse events (46 terms — click to expand)
| Reaction | System | TP-0903 Monotherapy (25mg … | TP-0903 and Ibrutinib Comb… |
|---|---|---|---|
| Lung Infection | Infections and infestations | — | — |
| Hives | Skin and subcutaneous tissue disorders | — | — |
| Geographic tongue with aphthous ulcers | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Decreased bilirubin level | Investigations | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Increased alkaline phosphatase level | Investigations | — | — |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | — | — |
| Weight gain | Investigations | — | — |
| Arthropod bite | Injury, poisoning and procedural complications | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Lymphocyte Count Increase | Investigations | — | — |
| Nail Infections | Infections and infestations | — | — |
| Fungal infection | Infections and infestations | — | — |
| Purpura | Skin and subcutaneous tissue disorders | — | — |
| Chills | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Increased Alanine Aminotransferase | Investigations | — | — |
| Increased Aspartate Aminotransferase | Investigations | — | — |
| Dsypnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — |
| Malaise | General disorders | — | — |
| Urinanry Incontience | Renal and urinary disorders | — | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Weight loss | Investigations | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Edema Limbs | General disorders | — | — |
| Delirium | Psychiatric disorders | — | — |
Most-reported serious reactions: Lung Infection, Increased Alanine Aminotransferase and Aspartate Aminotransferase levels, Pyrexia, Encephalopathy.
Data from ClinicalTrials.gov NCT03572634 adverse events section.
Sponsor's own description
TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-to-mesenchymal transitions. AXL was identified as a potential therapeutic target in chronic lymphocytic leukemia (CLL). TP 0903 was shown to induce apoptosis in CLL B-cells taken directly from patients.TP-0903 was equally potent against CLL cells regardless of risk-factor. TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers. TP-0903 has demonstrated profound single agent activity in CLL B cells taken directly from patients even if the patient has high risk factors (ie, 17p/P53 deletions) or progressed on other agents (ie, ibrutinib). TP-0903 is currently being evaluated in patients with refractory solid tumors (TP-0903-101). This proposed study is designed to identify the maximum tolerated dose (MTD), safety profile and recommended Phase 2 dose (RP2D) of TP-0903 in patients with previously treated CLL. Treatment cycles may be repeated if the patient continues to show benefit and if TP-0903 is reasonably well tolerated. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of TP-0903.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
EMT, MET, Plasticity, and Tumor Metastasis.
Bakir B, Chiarella AM, Pitarresi JR, Rustgi AK. · · 2020 · cited 770× · PMID 32800658 · DOI 10.1016/j.tcb.2020.07.003 -
AXL receptor tyrosine kinase as a promising anti-cancer approach: functions, molecular mechanisms and clinical applications.
Zhu C, Wei Y, Wei X. · · 2019 · cited 398× · PMID 31684958 · DOI 10.1186/s12943-019-1090-3 -
Targeting Tyro3, Axl and MerTK (TAM receptors): implications for macrophages in the tumor microenvironment.
Myers KV, Amend SR, Pienta KJ. · · 2019 · cited 333× · PMID 31088471 · DOI 10.1186/s12943-019-1022-2 -
Targeting multiple signaling pathways: the new approach to acute myeloid leukemia therapy.
Carter JL, Hege K, Yang J, Kalpage HA, et al · · 2020 · cited 148× · PMID 33335095 · DOI 10.1038/s41392-020-00361-x -
Lifting the innate immune barriers to antitumor immunity.
Rothlin CV, Ghosh S. · · 2020 · cited 63× · PMID 32273348 · DOI 10.1136/jitc-2020-000695 -
Therapeutic Targeting of the Gas6/Axl Signaling Pathway in Cancer.
Tanaka M, Siemann DW. · · 2021 · cited 60× · PMID 34576116 · DOI 10.3390/ijms22189953 -
The Role of the Receptor Tyrosine Kinase Axl in Carcinogenesis and Development of Therapeutic Resistance: An Overview of Molecular Mechanisms and Future Applications.
Wium M, Ajayi-Smith AF, Paccez JD, Zerbini LF. · · 2021 · cited 56× · PMID 33806258 · DOI 10.3390/cancers13071521 -
AXL as a Target in Breast Cancer Therapy.
Colavito SA. · · 2020 · cited 50× · PMID 32148495 · DOI 10.1155/2020/5291952
Verify or expand the search:
- PubMed search for NCT03572634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TP-0903
Trials testing the same drug.
- NCT02729298 — First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors · Phase 1 · completed
Other recruiting trials for Chronic Lymphocytic Leukemia
Currently open trials in the same condition.
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Other Sumitomo Pharma America, Inc. trials
Trials by the same sponsor.
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- NCT07492355 — TP-3654 Food Effect Study · Phase 1 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03572634 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma America, Inc.
- Last refreshed: 9 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03572634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing