15d
CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
P1, N=150, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: May 2024 --> Mar 2025
15 days ago
Trial primary completion date • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
28d
CR108998: A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (clinicaltrials.gov)
P1/2, N=350, Recruiting, Janssen Research & Development, LLC | N=150 --> 350 | Trial completion date: Feb 2026 --> Oct 2027
28 days ago
Enrollment change • Trial completion date
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NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
2ms
Preclinical efficacy of potent and selective menin-KMT2A inhibitor JNJ-75276617 in KMT2A- and NPM1-altered leukemias. (PubMed, Blood)
JNJ-75276617 demonstrated synergistic effects with gilteritinib in vitro in AML cells harboring KMT2A-r. JNJ-75276617 further exhibited synergistic effects with venetoclax and azacitidine in AML cells bearing KMT2A-r in vitro, and significantly increased survival in mice...A co-crystal structure of menin in complex with JNJ-75276617 indicates a unique binding mode distinct from other menin-KMT2A inhibitors, including revumenib. JNJ-75276617 is being clinically investigated for acute leukemias harboring KMT2A or NPM1 alterations, as a monotherapy for relapsed/refractory (R/R) acute leukemia (NCT04811560), or in combination with AML-directed therapies (NCT05453903).
2 months ago
Preclinical • Journal
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1)
|
Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine • revumenib (SNDX-5613) • bleximenib (JNJ-6617)
5ms
CR108998: A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1/2, N=150, Recruiting, Janssen Research & Development, LLC | Phase classification: P1 --> P1/2
5 months ago
Phase classification
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
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bleximenib (JNJ-6617)
6ms
CR108998: A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=150, Recruiting, Janssen Research & Development, LLC | N=110 --> 150
6 months ago
Enrollment change
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
9ms
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
P1, N=150, Recruiting, Janssen Research & Development, LLC | Phase classification: P1b --> P1
9 months ago
Phase classification • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
9ms
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov)
P1, N=80, Not yet recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Jan 2030
9 months ago
Trial completion date • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
|
cytarabine • vincristine • Oncaspar liquid (pegaspargase) • fludarabine IV • bleximenib (JNJ-6617)
10ms
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2025 --> Oct 2025
10 months ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
10ms
Preclinical Efficacy of the Menin-KMT2A Inhibitor JNJ-75276617 in Combination with Venetoclax and Azacitidine in AML (ASH 2023)
Hypomethylating agents (e.g. azacitidine, decitabine) in combination with venetoclax have significantly improved clinical outcomes for AML patients and have become a preferred frontline treatment for AML patients ≥75 years of age, or who have comorbidities that preclude use of intensive induction chemotherapy. These studies suggest that the doublet combinations of either JNJ-75276617 plus venetoclax or azacitidine, or the triplet combination could potentially provide a beneficial treatment option for KMT2A- or NPM1-altered AML, and support the recently initiated clinical trial investigating JNJ-75276617 in combination with AML-directed therapies, including venetoclax and azacitidine (NCT05453903). JNJ-75276617 is also being clinically investigated as a monotherapy for R/R acute leukemia (NCT04811560).
10 months ago
Preclinical • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1)
|
Venclexta (venetoclax) • azacitidine • decitabine • bleximenib (JNJ-6617)
10ms
A First-in-Human Phase 1 Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Adult Patients with Relapsed/Refractory Acute Leukemia Harboring KMT2A or NPM1 Alterations (ASH 2023)
Dose escalation in 75276617ALE1001 is ongoing with the RP2D(s) yet to be determined. Pts in dose expansion will receive JNJ-75276617 at the identified RP2D(s). Preliminary results of this FIH Phase 1 study demonstrate that JNJ-75276617 monotherapy has an acceptable safety profile, encouraging antileukemic activity, and emerging biologic activity consistent with the proposed mechanism of action in pts with R/R acute leukemia harboring KMT2A or NPM1 alterations.
10 months ago
Clinical • P1 data
|
FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • HOXA9 (Homeobox A9) • ITGAM (Integrin, alpha M) • MEIS1 (Meis Homeobox 1)
|
NPM1 mutation • MLLrearrangement
|
bleximenib (JNJ-6617)
over1year
Targeting the undruggable: menin inhibitors ante portas. (PubMed, J Cancer Res Clin Oncol)
To date at least six different menin-MLL inhibitors are undergoing clinical evaluation as first- and second-line monotherapy in acute leukaemias: DS-1594, BMF-219, JNJ-75276617, DSP-5336, revumenib, and ziftomenib, however, only for revumenib and ziftomenib early clinical data have been reported. The clinical development of novel menin-MLL inhibitors is well in line with the currently ongoing paradigm shift towards targeted therapies seen in the AML treatment landscape. Moreover, the clinical assessment of combinations of these inhibitors with established therapy options in AML could be the fuel for an improved outcome of MLL/NPM1 patients.
over 1 year ago
Review • Journal
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1)
|
NPM1 mutation • MLL rearrangement • MLLrearrangement • KMT2A expression • MLL fusion
|
revumenib (SNDX-5613) • ziftomenib (KO-539) • BMF-219 • bleximenib (JNJ-6617) • emilumenib succinate (DS-1594) • enzomenib (DSP-5336)
over1year
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2026 --> Jun 2025
over 1 year ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
over1year
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2025 --> Jun 2026
over 1 year ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
over1year
A Phase I/Ib Study of JNJ-75276617 in Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias Estudio fase I/Ib de JNJ-75276617 en sujetos pediátricos y adultos jóvenes con leucemias agudas en recaída o refractarias (clinicaltrialsregister.eu)
P1, N=80, Ongoing, Janssen-Cilag International NV
over 1 year ago
New P1 trial • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • HOXA9 (Homeobox A9) • NUP214 (Nucleoporin 214) • MEIS1 (Meis Homeobox 1)
|
bleximenib (JNJ-6617)
over1year
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov)
P1, N=80, Not yet recruiting, Janssen Research & Development, LLC | Initiation date: Dec 2022 --> Feb 2024
over 1 year ago
Trial initiation date • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
|
cytarabine • vincristine • Oncaspar liquid (pegaspargase) • fludarabine IV • bleximenib (JNJ-6617)
almost2years
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
P1b, N=150, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2024 --> Jan 2026
almost 2 years ago
Trial completion date • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
Venclexta (venetoclax) • azacitidine • bleximenib (JNJ-6617)
almost2years
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov)
P1, N=80, Not yet recruiting, Janssen Research & Development, LLC
almost 2 years ago
New P1 trial • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
|
cytarabine • vincristine • Oncaspar liquid (pegaspargase) • fludarabine IV • bleximenib (JNJ-6617)
2years
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2024 --> Jun 2025
2 years ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
2years
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
P1b, N=150, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
2 years ago
Enrollment open • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
Venclexta (venetoclax) • azacitidine • bleximenib (JNJ-6617)
2years
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
P1b, N=150, Not yet recruiting, Janssen Research & Development, LLC
2 years ago
New P1 trial • Combination therapy
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
Venclexta (venetoclax) • azacitidine • bleximenib (JNJ-6617)
2years
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2024 --> Aug 2024
2 years ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
almost3years
A Study of JNJ-75276617 in Participants With Acute Leukemia (clinicaltrials.gov)
P1, N=110, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2024 --> Apr 2024
almost 3 years ago
Trial completion date
|
NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
|
bleximenib (JNJ-6617)
