 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
10 News |  |
- | MAK683 / Novartis
Phase classification, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Jan 17, 2024
P1, N=139, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Phase classification: P1/2 --> P1
- Epigenetic Modifiers MMSET and EZH2 Physically Interact and Cooperate to Support Multiple Myeloma Pathophysiology (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2394;
Analysis of EZH2 expression levels and t(4;14) translocation status in 3 independent cohorts of MM patients (CoMMPass (N=674), UAMS-TT2 (N=345), Mtp-Daratumumab (N=51)) identified a worse overall survival of patients with high EZH2 expression combined with t(4;14) chromosomal translocation than patients with only one of these genetic events...Finally, we demonstrated that disrupting EZH2-MMSET interaction with MAK-683 may be of therapeutic interest, since MAK-683 combination with conventional drugs used in MM treatment, including melphalan and Panobinostat or BRD4 inhibitors, synergized to kill MM cells. Taken together, our data identified an ' EZH2 High t(4;14) + ' signature in MM patients with a poor outcome who may benefit from combination therapy of MAK-683 with melphalan or epidrugs.
- || MAK683 / Novartis
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Feb 21, 2023
P1/2, N=139, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Taken together, our data identified an ' EZH2 High t(4;14) + ' signature in MM patients with a poor outcome who may benefit from combination therapy of MAK-683 with melphalan or epidrugs. Trial completion date: Sep 2023 --> Jul 2024 | Trial primary completion date: Sep 2023 --> Jul 2024
- ||| MAK683 / Novartis
Enrollment closed, Enrollment change, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Nov 30, 2022
P1/2, N=139, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Sep 2023 --> Jul 2024 | Trial primary completion date: Sep 2023 --> Jul 2024 Recruiting --> Active, not recruiting | N=203 --> 139
- MAK683 / Novartis, Tazverik (tazemetostat) / Eisai, Ipsen
HJM-353: A potent, selective and orally bioavailable EED inhibitor with robust anti-tumor activities (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2324;
Conclusions In summary, HJM-353 is a potent, selective and orally bioavailable EED inhibitor with robust anti-tumor activities. We are developing HJM-353 for the treatment of hematological malignancies and solid tumors and expect to file an IND in the second half of 2022.
- || MAK683 / Novartis
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Jun 16, 2022
P1/2, N=203, Recruiting, Sponsor: Novartis Pharmaceuticals
We are developing HJM-353 for the treatment of hematological malignancies and solid tumors and expect to file an IND in the second half of 2022. Trial completion date: Nov 2022 --> Sep 2023 | Trial primary completion date: Oct 2022 --> Sep 2023
- MAK683 / Novartis
Pharmacokinetic and pharmacodynamic activity evaluation of MAK683, a selective oral embryonic ectoderm development (EED) inhibitor, in adults with advanced malignancies in a first-in-human study. (Available On Demand; 75) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5120;
P1/2
MAK683 has a PK profile supportive of QD or BID dosing in patients with advanced malignancies. Analysis of H3K27me3 in blood monocytes and tumor biopsy confirm the in vivo pharmacodynamic activity of MAK683.
- | MAK683 / Novartis
Journal: Discovery of the Clinical Candidate MAK683: An EED-Directed, Allosteric, and Selective PRC2 Inhibitor for the Treatment of Advanced Malignancies. (Pubmed Central) - Apr 19, 2022
Here, we report the stepwise optimization of the tool compound EED226 toward the potent and selective EED inhibitor MAK683 (compound 22) and its subsequent preclinical characterization. Based on a balanced PK/PD profile, efficacy, and mitigated risk of forming reactive metabolites, MAK683 has been selected for clinical development.
- | MAK683 / Novartis
Journal: Induction of senescence-associated secretory phenotype underlies the therapeutic efficacy of PRC2 inhibition in cancer. (Pubmed Central) - Apr 9, 2022
The genes potential regulated by PRC2 in neuroblastoma samples exhibited significant enrichment of ECM and senescence associated inflammation, supporting the clinical relevance of our results. Altogether, our results unravel the pharmacological mechanism of PRC2 inhibitors and propose a combination strategy for MAK683 and other PRC2 drugs.
- || MAK683 / Novartis
PK/PD data, Preclinical, Journal: Preclinical Pharmacokinetics and Metabolism of MAK683, a Clinical Stage Selective Oral Embryonic Ectoderm Development (EED) Inhibitor for Cancer Treatment. (Pubmed Central) - Mar 17, 2022
In addition, in-vivo biotransformation was also conducted in bile-duct cannulated (BDC) rat. The metabolism in BDC rat was similar to these observed the in vitro hepatocytes.
- || MAK683 / Novartis
Trial completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Nov 23, 2021
P1/2, N=203, Recruiting, Sponsor: Novartis Pharmaceuticals
The metabolism in BDC rat was similar to these observed the in vitro hepatocytes. Trial completion date: Aug 2022 --> Nov 2022
- MAK683 / Novartis
Phase I/II Study of MAK683 in Patients with Advanced Malignancies, Including Diffuse Large B-Cell Lymphoma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2992;
MAK683 was generally well tolerated and there were preliminary signs of activity in patients with treatment-resistant DLBCL. The use of MAK683 as a novel strategy for the inhibition of EED may have potential in relapsed/refractory DLBCL.
- MAK683 / Novartis
[VIRTUAL] Phase I/II study of MAK683 in patients (pts) with advanced malignancies including epithelioid sarcoma (Channel 5) - Jul 22, 2021 - Abstract #ESMO2021ESMO_1332;
P1/2
The use of MAK683 as a novel strategy for the inhibition of EED may have potential in relapsed/refractory DLBCL. MAK683 was generally well-tolerated and there were preliminary signs of activity in pts with advanced epithelioid sarcoma.
- || MAK683 / Novartis
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Feb 24, 2021
P1/2, N=203, Recruiting, Sponsor: Novartis Pharmaceuticals
MAK683 was generally well-tolerated and there were preliminary signs of activity in pts with advanced epithelioid sarcoma. Trial completion date: Jan 2021 --> Aug 2022 | Trial primary completion date: Jan 2021 --> Aug 2022
- || MAK683 / Novartis
Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Nov 20, 2019
P1/2, N=203, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jan 2021 --> Aug 2022 | Trial primary completion date: Jan 2021 --> Aug 2022 Trial primary completion date: Aug 2019 --> Jan 2021
- | MAK683 / Novartis
Enrollment change, Trial completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Jul 25, 2019
P1/2, N=203, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Aug 2019 --> Jan 2021 N=113 --> 203 | Trial completion date: Aug 2019 --> Jan 2021
- || MAK683 / Novartis
Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Apr 23, 2018
P1/2, N=113, Recruiting, Sponsor: Novartis Pharmaceuticals
N=113 --> 203 | Trial completion date: Aug 2019 --> Jan 2021 Trial primary completion date: Feb 2018 --> Aug 2019
- || MAK683 / Novartis
Trial primary completion date, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Mar 14, 2017
P1/2, N=113, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Feb 2018 --> Aug 2019 Trial primary completion date: Aug 2019 --> Feb 2018
- |||| MAK683 / Novartis
Enrollment open, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Oct 26, 2016
P1/2, N=113, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Aug 2019 --> Feb 2018 Not yet recruiting --> Recruiting
- ||||| MAK683 / Novartis
New P1/2 trial, Metastases: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies (clinicaltrials.gov) - Sep 14, 2016
P1/2, N=113, Not yet recruiting, Sponsor: Novartis Pharmaceuticals