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- ABTL0812 / Ability Pharma
Phase 2 clinical trial of the proautophagic drug ABTL0812 combined with paclitaxel and carboplatin in first-line patients with advanced squamous non-small cell lung carcinoma. (On Demand | Hall A; Poster Bd # 47) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3468;
P1/2
PK analysis is compatible with drug activity, and pharmacodynamic analysis shows drug engagement. Clinical trial information: NCT03366480.
- || ABTL0812 / Ability Pharma
Trial completion date, Trial primary completion date, Combination therapy, Metastases: PanC-ASAP: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study (clinicaltrials.gov) - Mar 29, 2023
P2, N=150, Recruiting, Sponsor: Ability Pharmaceuticals SL
Clinical trial information: NCT03366480. Trial completion date: Mar 2025 --> Sep 2028 | Trial primary completion date: Mar 2023 --> Dec 2024
- | ABTL0812 / Ability Pharma
Enrollment change, Trial completion date, Trial suspension, Trial primary completion date, Combination therapy, Metastases: A Study of ABTL0812 in Pancreatic Cancer (clinicaltrials.gov) - Feb 22, 2023
P1/2, N=60, Suspended, Sponsor: Ability Pharmaceuticals SL
Trial completion date: Mar 2025 --> Sep 2028 | Trial primary completion date: Mar 2023 --> Dec 2024 N=110 --> 60 | Trial completion date: Mar 2023 --> Apr 2024 | Not yet recruiting --> Suspended | Trial primary completion date: Mar 2022 --> Apr 2023
- | ABTL0812 / Ability Pharma
Journal: Anticancer effects of ABTL0812, a clinical stage drug inducer of autophagy-mediated cancer cell death, in glioblastoma models. (Pubmed Central) - Nov 22, 2022
Finally, we investigated the combination of ABTL0812 with the standard of care treatments for GBM radiotherapy and temozolomide in an orthotopic model, detecting that ABTL0812 potentiates the efficacy of both treatments and that the strongest effect is obtained with the triple combination of ABTL0812+radiotherapy+temozolomide. Overall, the present study demonstrated the anticancer efficacy of ABTL0812 as single agent and in combination with the GBM standard of care treatments in models of glioblastoma and supports the clinical investigation of ABTL0812 as a potential novel therapy for this aggressive brain tumor type.
- | ABTL0812 / Ability Pharma
Preclinical, Journal: ABTL0812 enhances antitumor effect of paclitaxel and reverts chemoresistance in triple-negative breast cancer models. (Pubmed Central) - Jun 22, 2022
Overall, the present study demonstrated the anticancer efficacy of ABTL0812 as single agent and in combination with the GBM standard of care treatments in models of glioblastoma and supports the clinical investigation of ABTL0812 as a potential novel therapy for this aggressive brain tumor type. No abstract available
- | ABTL0812 / Ability Pharma
Journal: The anti-cancer drug ABTL0812 induces ER stress-mediated cytotoxic autophagy by increasing dihydroceramide levels in cancer cells. (Pubmed Central) - Jan 1, 2022
P1/2
Finally, we found that MTORC1 inhibition and dihydroceramide accumulation synergized to induce autophagy and cytotoxicity, phenocopying the effect of ABTL0812. Given the fact that ABTL0812 is under clinical development, our findings support the hypothesis that manipulation of dihydroceramide levels might represents a new therapeutic strategy to target cancer.
- || ABTL0812 / Ability Pharma
Clinical, P1 data, Journal: A first-in-human phase I/Ib dose-escalation clinical trial of the autophagy inducer ABTL0812 in patients with advanced solid tumours. (Pubmed Central) - Sep 30, 2021
P1
ABTL0812 is safe and has an acceptable tolerability profile, allowing a long-term oral dosing. RP2D of 1300 mg three times a day was determined according to PK/PD modelling, and preliminary antitumour efficacy was observed.
- | ABTL0812 / Ability Pharma
Journal: The antitumour drug ABTL0812 impairs neuroblastoma growth through endoplasmic reticulum stress-mediated autophagy and apoptosis. (Pubmed Central) - Sep 16, 2021
Remarkably, ABTL0812 potentiated the antitumour activity of chemotherapies and differentiating agents such as irinotecan and 13-cis-retinoic acid. In conclusion, ABTL0812 distinctive mechanism of action makes it standout to be used alone or in combination in high-risk neuroblastoma patients.
- ||| ABTL0812 / Ability Pharma
Enrollment open, Combination therapy, Metastases: PanC-ASAP: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study (clinicaltrials.gov) - Jun 25, 2021
P2, N=150, Recruiting, Sponsor: Ability Pharmaceuticals SL
In conclusion, ABTL0812 distinctive mechanism of action makes it standout to be used alone or in combination in high-risk neuroblastoma patients. Not yet recruiting --> Recruiting
- ||| ABTL0812 / Ability Pharma
Trial completion, Combination therapy, Metastases: Endolung: A Study to Assess the Efficacy and Safety of ABTL0812 (clinicaltrials.gov) - Jun 23, 2021
P1/2, N=103, Completed, Sponsor: Ability Pharmaceuticals SL
Not yet recruiting --> Recruiting Recruiting --> Completed
- | ABTL0812 / Ability Pharma, SciClone
Journal: The novel pro-autophagy anticancer drug ABTL0812 potentiates chemotherapy in adenocarcinoma and squamous Non-Small Cell Lung Cancer. (Pubmed Central) - Apr 7, 2021
We also present preliminary clinical data indicating that TRIB3 could serve as a potential novel pharmacodynamic biomarker to monitor ABTL0812 activity administered alone or in combination with chemotherapy in squamous NSCLC patients. The safety profile of ABTL0812 and its good synergy with chemotherapy potentiate the therapeutic potential of current lines of treatment based on chemotherapy regimens, arising as a promising option for improving these patient's therapeutic expectancy.
- ABTL0812 / Ability Pharma, SciClone
[VIRTUAL] ABTL0812, a Phase 2 clinical stage pro-autophagy anticancer drug exhibits immunomodulatory effects that modify tumor microenvironment in pancreatic cancer models () - Mar 11, 2021 - Abstract #AACR2021AACR_2996;
Overall, these multiple actions could potentially help to transform “cold” non-immunogenic tumors into “hot” immunogenic tumors and contribute to elicit anticancer immunosurveillance. These novel findings support further investigation of ABTL0812 in combination with immunotherapy to treat cancer
- || ABTL0812 / Ability Pharma
Trial completion date, Trial primary completion date, Combination therapy, Metastases: PanC-ASAP: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study (clinicaltrials.gov) - Feb 11, 2021
P2, N=150, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
These novel findings support further investigation of ABTL0812 in combination with immunotherapy to treat cancer Trial completion date: Dec 2022 --> Mar 2025 | Trial primary completion date: Sep 2022 --> Mar 2023
- || ABTL0812 / Ability Pharma
Trial initiation date, Combination therapy, Metastases: PanC-ASAP: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study (clinicaltrials.gov) - Feb 10, 2021
P2, N=150, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
Trial completion date: Dec 2022 --> Mar 2025 | Trial primary completion date: Sep 2022 --> Mar 2023 Initiation date: Dec 2020 --> Mar 2021
- ABTL0812 / Ability Pharma, SciClone
[VIRTUAL] Phase 2 of Pro-Autophagic Drug ABTL0812 in Combination With First-Line Paclitaxel and Carboplatin in IIIb/IV Squamous NSCLC (Scientific Program Auditorium) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1701;
There is a trend to increased efficacy with no increased toxicity and an acceptable safety and tolerability profile. PK and PD profiles indicate sustained target modulation.
- carboplatin / Generic mfg., paclitaxel / Generic mfg.
[VIRTUAL] Phase II of ABTL0812, a pro-autophagic drug, in combination with paclitaxel and carboplatin (P/C) as first-line treatment in advanced/recurrent endometrial cancer (On-Demand) - Jul 21, 2020 - Abstract #ESMO2020ESMO_1114;
P1/2
Funding: Ability Pharmaceuticals SL. Clinical trial identification: EudraCT: 2016-001352-21.
- |||| ABTL0812 / Ability Pharma
New P2 trial, Combination therapy, Metastases: PanC-ASAP: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study (clinicaltrials.gov) - Jun 15, 2020
P2, N=150, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
- Afinitor (everolimus) / Novartis, ABTL0812 / Ability Pharma, SciClone
The anticancer drug ABTL0812 induces cancer cell death by impairing Akt/mTORC1 axis and inducing ER stress-mediated cytotoxic autophagy (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2989;
To our knowledge, this is the first time that UPR markers are reported to change in human blood in response to any drug treatment. In conclusion, we have shown that ABTL0812 triggers a sustained ER stress and UPR activation mediated by the impairment of Des-1 activity which collaborates with mTORC1 inhibition to induce cytotoxic autophagy in cancer cells, which offers improved anticancer activity over just inhibiting mTORC1.
- ABTL0812 / Ability Pharma, SciClone
ABTL 0812 (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_305;
- || ABTL0812 / Ability Pharma
Trial primary completion date, Combination therapy, Metastases: Endolung: A Study to Assess the Efficacy and Safety of ABTL0812 (clinicaltrials.gov) - Jan 13, 2020
P1/2, N=80, Recruiting, Sponsor: Ability Pharmaceuticals SL
In conclusion, we have shown that ABTL0812 triggers a sustained ER stress and UPR activation mediated by the impairment of Des-1 activity which collaborates with mTORC1 inhibition to induce cytotoxic autophagy in cancer cells, which offers improved anticancer activity over just inhibiting mTORC1. Trial primary completion date: Dec 2019 --> Jun 2020
- ABTL0812 / Ability Pharma, SciClone, paclitaxel / Generic Mfg.
Preclinical evidences of the therapeutic potential of ABTL0812 in endometrial cancer () - Oct 16, 2019 - Abstract #ESGO2019ESGO_2015;
ABTL0812 efficacy was evaluated in tumor onset and progression in a tamoxifen-inducible PTEN-KO murine model and cell line- or patient-derived xenograft (PDX) models...ABTL0812 in vivo therapeutic benefit was confirmed, leading to a marked reduction in tumor growth (p<0.05), impairing the initial progression of endometrial tumorigenesis in PTEN-KO mouse model, and inhibiting tumor progression in PDX models, potentiating carboplatin-paclitaxel treatment...Collectively, we provided strong preclinical evidences of the therapeutic benefit of ABTL0812 as monotherapy or in combination with current first-line treatment in EC. Our findings present a novel and clinically applicable therapeutic strategy for EC and suggest the potential use of TRIB3 as a pharmacodynamic biomarker to monitor ABTL0812 treatment.
- | ABTL0812 / Ability Pharma, SciClone
Biomarker, Journal: Therapeutic potential of the new TRIB3-mediated cell autophagy anticancer drug ABTL0812 in endometrial cancer. (Pubmed Central) - Jul 4, 2019
Our findings present a novel and clinically applicable therapeutic strategy for EC and suggest the potential use of TRIB3 as a pharmacodynamic biomarker to monitor ABTL0812 treatment. ABTL0812 may represent a novel and highly effective therapeutic agent by inducing TRIB3 expression and autophagy in EC patients, including those with poorer prognosis.
- || ABTL0812 / Ability Pharma
Trial initiation date, Combination therapy, Metastases: A Study of ABTL0812 in Pancreatic Cancer (clinicaltrials.gov) - Feb 4, 2019
P1/2, N=110, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
ABTL0812 may represent a novel and highly effective therapeutic agent by inducing TRIB3 expression and autophagy in EC patients, including those with poorer prognosis. Initiation date: Apr 2019 --> Dec 2019
- | ABTL0812 / Ability Pharma
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: A Study of ABTL0812 in Pancreatic Cancer (clinicaltrials.gov) - Sep 28, 2018
P1/2, N=110, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
Initiation date: Apr 2019 --> Dec 2019 N=46 --> 110 | Trial completion date: Sep 2020 --> Mar 2023 | Initiation date: Sep 2018 --> Apr 2019 | Trial primary completion date: Sep 2020 --> Mar 2022
- | ABTL0812 / Ability Pharma
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Endolung: A Study to Assess the Efficacy and Safety of ABTL0812 (clinicaltrials.gov) - Sep 10, 2018
P1/2, N=80, Recruiting, Sponsor: Ability Pharmaceuticals SL
N=46 --> 110 | Trial completion date: Sep 2020 --> Mar 2023 | Initiation date: Sep 2018 --> Apr 2019 | Trial primary completion date: Sep 2020 --> Mar 2022 Trial completion date: Nov 2018 --> Nov 2020 | Trial primary completion date: Dec 2017 --> Dec 2019
- | ABTL0812 / Ability Pharma
New P1/2 trial, Combination therapy, Metastases: A Study of ABTL0812 in Pancreatic Cancer (clinicaltrials.gov) - Jan 30, 2018
P1/2, N=46, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
- ||||| ABTL0812 / Ability Pharma
New P1/2 trial, Combination therapy, Metastases: Endolung: A Study to Assess the Efficacy and Safety of ABTL0812 (clinicaltrials.gov) - Dec 8, 2017
P1/2, N=80, Recruiting, Sponsor: Ability Pharmaceuticals SL
- | ABTL0812 / Ability Pharma
New P1/2 trial, P1/2 data, Combination therapy, Metastases: A Phase I/II Study of ABTL0812 (Pancreatic) (clinicaltrials.gov) - Dec 5, 2017
P1/2, N=46, Not yet recruiting, Sponsor: Ability Pharmaceuticals SL
- ABTL0812 / Ability Pharma
Trial completion, Trial primary completion date, Metastases: Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients (clinicaltrials.gov) - Jul 2, 2015
P1, N=27, Completed, Sponsor: Ability Pharmaceuticals SL
Trial completion date: Nov 2018 --> Nov 2020 | Trial primary completion date: Dec 2017 --> Dec 2019 Recruiting --> Completed | Trial primary completion date: Dec 2014 --> Mar 2015