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- ASTX295 / Otsuka
ASTX295 a Novel Potent MDM2 Antagonist Induces More Than One Mechanism of Programmed Cell Death (PCD) in Lymphoid Malignancies (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3881;
P1/2
ASTX295 like other MDM2i showed synergy with BCL2i in DLBCL and MCL models. ASTX295 induced multiple forms of PCD; the precise form of non-caspase dependent PCD remains under investigation.
- ASTX295 / Otsuka
Pulsatile induction of the p53 pathway by MDM2 antagonist ASTX295 shows an enhanced therapeutic index in vivo (Exhibition Hall) - Sep 7, 2024 - Abstract #EORTCNCIAACR2024EORTC_NCI_AACR_394;
Unless they are part of the media programme, embargoed or not consented, all abstracts will be released on 9 October 2024. All other abstracts will be released on the day of presentation.
- ASTX295 / Otsuka
Identification of biomarkers predictive of response to ASTX295, a next-generation MDM2 antagonist, in solid tumors carrying wild-type p53 (Exhibition Hall) - Sep 7, 2024 - Abstract #EORTCNCIAACR2024EORTC_NCI_AACR_170;
Unless they are part of the media programme, embargoed or not consented, all abstracts will be released on 9 October 2024. All other abstracts will be released on the day of presentation.
- ||| ASTX295 / Otsuka
Enrollment change, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Sep 4, 2024
P1/2, N=106, Active, not recruiting, Sponsor: Taiho Oncology, Inc.
All other abstracts will be released on the day of presentation. N=250 --> 106
- || ASTX295 / Otsuka
Trial primary completion date, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Aug 1, 2024
P1/2, N=250, Active, not recruiting, Sponsor: Taiho Oncology, Inc.
N=250 --> 106 Trial primary completion date: Dec 2024 --> May 2024
- ASTX295 / Otsuka
Discovery of ASTX295, a potent, next-generation small molecule antagonist of MDM2 with differentiated pharmacokinetic profile (Ballroom 6 DE - Upper Level - Convention Center) - Mar 5, 2024 - Abstract #AACR2024AACR_8827;
P1/2
These data highlight the therapeutic potential of ASTX295, which is currently being tested in a Phase 1/2 clinical trial in advanced solid tumors with wild-type p53 (NCT03975387). We plan to present preliminary clinical data in a separate abstract at this meeting.
- ASTX295 / Otsuka
Targeting the MDM2-p53 interaction: Time- and concentration-dependent studies in tumor and normal human bone marrow cells reveal strategies for an enhanced therapeutic index (Section 28) - Mar 5, 2024 - Abstract #AACR2024AACR_5485;
P1/2
Hence, intermittent exposure to an MDM2-p53 antagonist could favourably modulate its therapeutic index. The predicted short plasma half-life of ASTX295 should provide flexibility in controlling the duration of exposure in vivo, potentially enabling a more bone-marrow sparing approach to MDM2-p53 antagonism to be utilised.
- ASTX295 / Otsuka
Phase 1 study of MDM2 antagonist ASTX295 in patients with solid tumors with wild-type TP53 (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_3866;
The predicted short plasma half-life of ASTX295 should provide flexibility in controlling the duration of exposure in vivo, potentially enabling a more bone-marrow sparing approach to MDM2-p53 antagonism to be utilised. Abstract is embargoed at this time.
- ASTX295 / Otsuka
Identification of biomarkers of response to MDM2 inhibition in solid tumours using computational, multi-omics approaches (Section 27) - Mar 5, 2024 - Abstract #AACR2024AACR_2696;
Further, pathway and transcriptional regulator analysis identified the Interferon signalling as significantly enriched in apoptotic cell lines and was confirmed in a TCGA mesothelioma patient data set and the module was found to be significantly correlated with a subgroup of P53 wild-type patients with CDKN2A loss. In conclusion, combining cell panel drug screening with co-expression networks helped to identify biomarkers associated with ASTX295 sensitivity, and provided new insights into the underlying mechanism of ASTX295 response.
- ASTX295 / Otsuka
ASTX295 engages p53-mediated apoptosis and an inflammatory response in patient derived mesothelioma explants (Section 27) - Mar 5, 2024 - Abstract #AACR2024AACR_2695;
P1/2
In summary, inhibition of MDM2-P53 interaction triggers robust p53 activation and a pro-inflammatory phenotype, which is potentiated in EMT enriched mesothelioma PDEs. ASTX295 is currently under clinical investigation (NCT03975387).
- || ASTX295 / Otsuka
Trial primary completion date, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Nov 1, 2023
P1/2, N=250, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
ASTX295 is currently under clinical investigation (NCT03975387). Trial primary completion date: Jun 2025 --> Dec 2024
- ||| ASTX295 / Otsuka
Enrollment closed, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Sep 11, 2023
P1/2, N=250, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Trial primary completion date: Jun 2025 --> Dec 2024 Recruiting --> Active, not recruiting
- ||| ASTX295 / Otsuka
Enrollment change, Trial completion date, Trial primary completion date, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Aug 24, 2022
P1/2, N=250, Recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting N=191 --> 250 | Trial completion date: May 2023 --> Aug 2025 | Trial primary completion date: Apr 2023 --> Jun 2025
- ||| ASTX295 / Otsuka
Enrollment open, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Aug 12, 2021
P1/2, N=191, Recruiting, Sponsor: Astex Pharmaceuticals, Inc.
N=191 --> 250 | Trial completion date: May 2023 --> Aug 2025 | Trial primary completion date: Apr 2023 --> Jun 2025 Active, not recruiting --> Recruiting
- || ASTX295 / Otsuka
Enrollment closed, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Jun 16, 2021
P1/2, N=191, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||| ASTX295 / Otsuka
Enrollment change, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Jun 8, 2021
P1/2, N=191, Recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting N=135 --> 191
- ||| ASTX295 / Otsuka
Enrollment open, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - May 27, 2020
P1/2, N=135, Recruiting, Sponsor: Astex Pharmaceuticals, Inc.
N=135 --> 191 Active, not recruiting --> Recruiting
- decitabine / Generic mfg.
[VIRTUAL] ASTX295, A NOVEL SMALL MOLECULE MDM2 ANTAGONIST, DEMONSTRATES POTENT ACTIVITY IN AML IN COMBINATION WITH DECITABINE () - May 16, 2020 - Abstract #EHA2020EHA_751;
P1/2
Target engagement of ASTX295 and decitabine was confirmed by upregulation of p53 transcriptional targets and decreased DNMT-1 expression. Conclusion Our findings demonstrate that the combination of ASTX295 with decitabine exhibits potent activity against p53 wild-type AML cells, and thus merits further investigation.
- || ASTX295 / Otsuka
Enrollment closed, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Mar 19, 2020
P1/2, N=135, Active, not recruiting, Sponsor: Astex Pharmaceuticals, Inc.
Conclusion Our findings demonstrate that the combination of ASTX295 with decitabine exhibits potent activity against p53 wild-type AML cells, and thus merits further investigation. Recruiting --> Active, not recruiting
- | ASTX295 / Otsuka
Enrollment open, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Jul 31, 2019
P1/2, N=135, Recruiting, Sponsor: Astex Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||| ASTX295 / Otsuka
Preclinical: Small-molecule MDM2 antagonist ASTX-295 induces apoptosis in primary AML blast cells and demonstrates in vivo efficacy in an AML systemic mouse model @EHA_Hematology #EHA24 (Twitter) - Jun 15, 2019
- |||| ASTX295 / Otsuka
New P1/2 trial, Metastases: Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53 (clinicaltrials.gov) - Jun 4, 2019
P1/2, N=135, Not yet recruiting, Sponsor: Astex Pharmaceuticals