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DRUG CLASS:

STAMP inhibitor

2d
New P2 trial
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ABL1 (ABL proto-oncogene 1)
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ABL1 fusion
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dasatinib • Scemblix (asciminib)
2d
Asciminib RMP Study (clinicaltrials.gov)
P=N/A, N=600, Recruiting, Novartis Pharmaceuticals | N=100 --> 600 | Trial completion date: Jul 2025 --> Jun 2030 | Trial primary completion date: Jul 2025 --> Jun 2030
Enrollment change • Trial completion date • Trial primary completion date
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Scemblix (asciminib)
5d
ASC4INDIA: Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation (clinicaltrials.gov)
P4, N=85, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Nov 2026 --> Mar 2026 | Trial primary completion date: Nov 2026 --> Mar 2026
Trial completion • Trial completion date • Trial primary completion date
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ABL1 (ABL proto-oncogene 1)
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ABL1 T315I
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Scemblix (asciminib)
14d
Targeting leukemic stem and progenitor cells expressing different BCR::ABL1 levels: antileukemic activity of asciminib with or without TKIs. (PubMed, Front Pharmacol)
We investigated the cytotoxic effects of ASC, alone or with imatinib (IM) or nilotinib (NIL), on committed progenitors and LSCs from CML patients expressing high or low BCR::ABL1 at diagnosis. When combined with IM or NIL, ASC restored TKI activity against LTC-ICs expressing high BCR::ABL1 transcripts, with the association of ASC and NIL reducing both LTC-IC division rates and LTC-IC-derived CFUs. These findings suggest that ASC, alone or with NIL, may target LSCs and improve outcomes in patients with high BCR::ABL1 expression at diagnosis.
Journal
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ABL1 (ABL proto-oncogene 1)
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ABL1 T315I
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imatinib • nilotinib • Scemblix (asciminib)
20d
AsterA: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia (clinicaltrials.gov)
P2, N=69, Recruiting, Korean Society of Hematology | Not yet recruiting --> Recruiting
Enrollment open
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Scemblix (asciminib)
21d
ASC4CN: Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China (clinicaltrials.gov)
P=N/A, N=200, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open • Real-world evidence
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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Scemblix (asciminib)
22d
Postmarketing surveillance study of asciminib in patients with resistant/intolerant chronic myeloid leukemia in Japan. (PubMed, Int J Hematol)
Cumulative MR4.0 and MR4.5 rates by week 48 were 42.3% and 26.5%, respectively, with some patients harboring baseline BCR::ABL1 mutations showing these responses. These real-world outcomes support the safety and effectiveness of asciminib for patients with resistant/intolerant CML.
P4 data • Journal
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ABL1 (ABL proto-oncogene 1)
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Scemblix (asciminib)
28d
CMLXI: Frontline Asciminib Combination in Chronic Phase CML (clinicaltrials.gov)
P2, N=125, Active, not recruiting, University of Jena | Not yet recruiting --> Active, not recruiting
Enrollment closed
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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dasatinib • imatinib • nilotinib • Scemblix (asciminib)
28d
New P2 trial
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dasatinib • imatinib • nilotinib • Scemblix (asciminib)
1m
ASC4OPT: Asciminib Treatment Optimization in ≥ 3rd Line CML-CP (clinicaltrials.gov)
P3, N=199, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
Trial completion
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Scemblix (asciminib)
1m
Pharmacokinetics of Asciminib 200 mg in the Presence of a Strong CYP3A4 Inducer, Phenytoin, in Healthy Participants. (PubMed, Clin Pharmacokinet)
These data support that, considering its large therapeutic window, asciminib 200 mg twice daily can be used without any dose adjustment when co-administered with a strong CYP3A4 inducer drug. Furthermore, asciminib is not an OATP1B inhibitor up to this dose.
PK/PD data • Journal
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CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
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Scemblix (asciminib)
1m
Asciminib With or Without Sildenafil for Brain Tumors (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Washington University School of Medicine | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Jul 2027 --> Oct 2027
Trial completion date • Trial primary completion date
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CRKL (CRK Like Proto-Oncogene, Adaptor Protein) • ABL2 (ABL Proto-Oncogene 2, Non-Receptor Tyrosine Kinase)
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Scemblix (asciminib) • sildenafil