Pancreatic CancerPhase 1/2PancreaticNCT03417921
A Study of ABTL0812 in Pancreatic Cancer
A Phase 1/2 study testing ABTL0812 and Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Ability Pharmaceuticals SL at 1 site in Spain.
Trial summary
A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ABTL0812 and Gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 26 Apr 2021to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age
- Willing and able to provide informed consent
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
- Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
- Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media).
- Patient has not received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Show all 43Show fewer
- Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Adequate hematologic function, measured as:
- absolute neutrophil count ≥ 1.5x109/L
- platelet count ≥ 100x109/L
- hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x ULN
- Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) and ALT (SGPT) < 2.5 times x upper limit of normal (≤5 times the ULN in patients with evidence of liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases)
- Serum creatinine ≤1.5 ULN
- Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
- Life expectancy ≥ 12 weeks in the opinion of the investigator
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one "target lesion" to be used to assess response. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented
- Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
- Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.03).
- Patients fulfilling the following criteria are eligible for participation in the study:
- Patients ≥18 years of age
- Willing and able to provide informed consent
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
- Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
- Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media).
- Patient has not received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Adequate hematologic function, measured as:
- absolute neutrophil count ≥ 1.5x109/L
- platelet count ≥ 100x109/L
- hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x ULN
- Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) and ALT (SGPT) < 2.5 times x upper limit of normal (≤5 times the ULN in patients with evidence of liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases)
- Serum creatinine ≤1.5 ULN
- Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
- Life expectancy ≥ 12 weeks in the opinion of the investigator
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one "target lesion" to be used to assess response. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented
- Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
- Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.03).
Who cannot join
- Patients who meet one of more of the following criteria are not eligible:
- Patients with neuroendocrine tumors or cystic neoplasms are excluded
- Patient has received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
- Patient has only locally advanced disease.
- Patients has symptomatic brain metastases. Patients with asymptomatic brain metastases can be included in the study if they are kept on stable doses of steroids for a period of 1 month prior to study entry provided they don't have peripheric neuropathy grade 2 or superior.
- Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway
Show all 12Show fewer
- Patients has gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product.
- Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start.
- Patients had myocardial infarction within ≤ 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
- Evidence of pre-existing uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Patients has active Hepatitis B or C or human immunodeficiency virus (HIV) infection with non-controlled disease according to the treating physician.
- Patients with any other medical conditions (such as psychiatric illness, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy
A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy.
Read the detailed description
This is an open-label, randomized phase I/II multicenter study to evaluate ABTL0812 in combination with gemcitabine and nab-paclitaxel at first line therapy. Patients will be assigned to the following groups during the study conduct:
- GROUP A: You will receive the standard treatment of chemotherapy and the investigational drug ABTL0812.
- GROUP B: You will receive the standard treatment of chemotherapy.
For GROUP A:
Phase I: A 3+3 de-escalation design followed by an expansion phase will be performed
- ABTL0812 will be administered chronically daily. Potential dose levels are 1300 mg tid, 1000 mg tid, 650 mg tid and 500 mg tid. Intrapatient escalation or de-escalation is not permitted. A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
- Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.
- If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.
Phase II:
- ABTL0812 will be administered chronically daily at the Recommended Phase 2 Dose (RP2D). A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
- Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 IV + nab-paclitaxel 125 mg/m2 IV on days 1, 8 and 15
- If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.
- Conditions
- Pancreatic Cancer
- Being tested
- ABTL0812, Gemcitabine and nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTL0812Drug
ABTL0812 in combination with gemcitabine and nab-paclitaxel
Gemcitabine and nab-paclitaxelDrug
Gemcitabine and nab-paclitaxel as standard pattern
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | ABTL0812 (starting 1,300 mg tid orally) in combination with gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer Receives: Drug: ABTL0812; Drug: Gemcitabine and nab-paclitaxel |
| ARM B | Active comparator | Gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer as standard pattern Receives: Drug: Gemcitabine and nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergent Adverse Events
Related Adverse Events as Assessed by CTCAE v4.03
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start26 Apr 2021
- Primary completion26 Apr 2023
- Study completion31 Dec 2025 (estimated)
Why it stopped: We opened another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ability Pharmaceuticals SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Carles Domènech, PhD, Study director, Ability Pharmaceuticals SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417921
- Sponsor's protocol ID
- ABT-C6-2017
- Acronym
- Pancreatic
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erazo T, Lorente M, Lopez-Plana A, Munoz-Guardiola P, Fernandez-Nogueira P, Garcia-Martinez JA, Bragado P, Fuster G, Salazar M, Espadaler J, Hernandez-Losa J, Bayascas JR, Cortal M, Vidal L, Gascon P, Gomez-Ferreria M, Alfon J, Velasco G, Domenech C, Lizcano JM. The New Antitumor Drug ABTL0812 Inhibits the Akt/mTORC1 Axis by Upregulating Tribbles-3 Pseudokinase. Clin Cancer Res. 2016 May 15;22(10):2508-19. doi: 10.1158/1078-0432.CCR-15-1808. Epub 2015 Dec 15.
PubMed 26671995Munoz-Guardiola P, Casas J, Megias-Roda E, Sole S, Perez-Montoyo H, Yeste-Velasco M, Erazo T, Dieguez-Martinez N, Espinosa-Gil S, Munoz-Pinedo C, Yoldi G, Abad JL, Segura MF, Moran T, Romeo M, Bosch-Barrera J, Oaknin A, Alfon J, Domenech C, Fabrias G, Velasco G, Lizcano JM. The anti-cancer drug ABTL0812 induces ER stress-mediated cytotoxic autophagy by increasing dihydroceramide levels in cancer cells. Autophagy. 2021 Jun;17(6):1349-1366. doi: 10.1080/15548627.2020.1761651. Epub 2020 May 25.
PubMed 32397857Felip I, Moiola CP, Megino-Luque C, Lopez-Gil C, Cabrera S, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Alfon J, Yeste-Velasco M, Santacana M, Dolcet X, Reques A, Oaknin A, Rodriguez-Freixinos V, Lizcano JM, Domenech C, Gil-Moreno A, Matias-Guiu X, Colas E, Eritja N. Therapeutic potential of the new TRIB3-mediated cell autophagy anticancer drug ABTL0812 in endometrial cancer. Gynecol Oncol. 2019 May;153(2):425-435. doi: 10.1016/j.ygyno.2019.03.002. Epub 2019 Mar 7.
PubMed 30853360Lopez-Plana A, Fernandez-Nogueira P, Munoz-Guardiola P, Sole-Sanchez S, Megias-Roda E, Perez-Montoyo H, Jauregui P, Yeste-Velasco M, Gomez-Ferreria M, Erazo T, Ametller E, Recalde-Percaz L, Moragas-Garcia N, Noguera-Castells A, Mancino M, Moran T, Nadal E, Alfon J, Domenech C, Gascon P, Lizcano JM, Fuster G, Bragado P. The novel proautophagy anticancer drug ABTL0812 potentiates chemotherapy in adenocarcinoma and squamous nonsmall cell lung cancer. Int J Cancer. 2020 Aug 15;147(4):1163-1179. doi: 10.1002/ijc.32865. Epub 2020 Feb 6.
PubMed 31943158Vidal L, Victoria I, Gaba L, Martin MG, Brunet M, Colom H, Cortal M, Gomez-Ferreria M, Yeste-Velasco M, Perez A, Rodon J, Sohal DPS, Lizcano JM, Domenech C, Alfon J, Gascon P. A first-in-human phase I/Ib dose-escalation clinical trial of the autophagy inducer ABTL0812 in patients with advanced solid tumours. Eur J Cancer. 2021 Mar;146:87-94. doi: 10.1016/j.ejca.2020.12.019. Epub 2021 Feb 12.
PubMed 33588149Paris-Coderch L, Soriano A, Jimenez C, Erazo T, Munoz-Guardiola P, Masanas M, Antonelli R, Boloix A, Alfon J, Perez-Montoyo H, Yeste-Velasco M, Domenech C, Roma J, Sanchez de Toledo J, Moreno L, Lizcano JM, Gallego S, Segura MF. The antitumour drug ABTL0812 impairs neuroblastoma growth through endoplasmic reticulum stress-mediated autophagy and apoptosis. Cell Death Dis. 2020 Sep 17;11(9):773. doi: 10.1038/s41419-020-02986-w.
PubMed 32943619Mancini A, Colapietro A, Cristiano L, Rossetti A, Mattei V, Gravina GL, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Domenech C, Festuccia C. Anticancer effects of ABTL0812, a clinical stage drug inducer of autophagy-mediated cancer cell death, in glioblastoma models. Front Oncol. 2022 Nov 2;12:943064. doi: 10.3389/fonc.2022.943064. eCollection 2022.
PubMed 36408162
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy
- ClinicalTrials.gov ID
- NCT03417921
- Acronym / sponsor ID
- Pancreatic / ABT-C6-2017
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We opened another study.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ability Pharmaceuticals SLIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy.
Detailed description
This is an open-label, randomized phase I/II multicenter study to evaluate ABTL0812 in combination with gemcitabine and nab-paclitaxel at first line therapy. Patients will be assigned to the following groups during the study conduct:
- GROUP A: You will receive the standard treatment of chemotherapy and the investigational drug ABTL0812.
- GROUP B: You will receive the standard treatment of chemotherapy.
For GROUP A:
Phase I: A 3+3 de-escalation design followed by an expansion phase will be performed
- ABTL0812 will be administered chronically daily. Potential dose levels are 1300 mg tid, 1000 mg tid, 650 mg tid and 500 mg tid. Intrapatient escalation or de-escalation is not permitted. A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
- Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.
- If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.
Phase II:
- ABTL0812 will be administered chronically daily at the Recommended Phase 2 Dose (RP2D). A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
- Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 IV + nab-paclitaxel 125 mg/m2 IV on days 1, 8 and 15
- If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: ABTL0812, Drug: Gemcitabine and nab-paclitaxelABTL0812 (starting 1,300 mg tid orally) in combination with gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer |
| ARM B | Active comparator | Drug: Gemcitabine and nab-paclitaxelGemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer as standard pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- Patients ≥18 years of age
- Willing and able to provide informed consent
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
- Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
- Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media).
Key exclusion criteria (12 listed)
- Patients with neuroendocrine tumors or cystic neoplasms are excluded
- Patient has received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
- Patient has only locally advanced disease.
- Patients has symptomatic brain metastases. Patients with asymptomatic brain metastases can be included in the study if they are kept on stable doses of steroids for a period of 1 month prior to study entry provided they don't have peripheric neuropathy grade 2 or superior.
- Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABTL0812ABTL0812 in combination with gemcitabine and nab-paclitaxel | Drug | ARM A |
| Gemcitabine and nab-paclitaxelGemcitabine and nab-paclitaxel as standard pattern | Drug | ARM A, ARM B |
Primary outcome
Emergent Adverse Events
Time frame: 1 year
Related Adverse Events as Assessed by CTCAE v4.03
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 26671995Erazo T, Lorente M, Lopez-Plana A, Munoz-Guardiola P, Fernandez-Nogueira P, Garcia-Martinez JA, Bragado P, Fuster G, Salazar M, Espadaler J, Hernandez-Losa J, Bayascas JR, Cortal M, Vidal L, Gascon P, Gomez-Ferreria M, Alfon J, Velasco G, Domenech C, Lizcano JM. The New Antitumor Drug ABTL0812 Inhibits the Akt/mTORC1 Axis by Upregulating Tribbles-3 Pseudokinase. Clin Cancer Res. 2016 May 15;22(10):2508-19. doi: 10.1158/1078-0432.CCR-15-1808. Epub 2015 Dec 15.
- Background: PubMed 32397857Munoz-Guardiola P, Casas J, Megias-Roda E, Sole S, Perez-Montoyo H, Yeste-Velasco M, Erazo T, Dieguez-Martinez N, Espinosa-Gil S, Munoz-Pinedo C, Yoldi G, Abad JL, Segura MF, Moran T, Romeo M, Bosch-Barrera J, Oaknin A, Alfon J, Domenech C, Fabrias G, Velasco G, Lizcano JM. The anti-cancer drug ABTL0812 induces ER stress-mediated cytotoxic autophagy by increasing dihydroceramide levels in cancer cells. Autophagy. 2021 Jun;17(6):1349-1366. doi: 10.1080/15548627.2020.1761651. Epub 2020 May 25.
- Background: PubMed 30853360Felip I, Moiola CP, Megino-Luque C, Lopez-Gil C, Cabrera S, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Alfon J, Yeste-Velasco M, Santacana M, Dolcet X, Reques A, Oaknin A, Rodriguez-Freixinos V, Lizcano JM, Domenech C, Gil-Moreno A, Matias-Guiu X, Colas E, Eritja N. Therapeutic potential of the new TRIB3-mediated cell autophagy anticancer drug ABTL0812 in endometrial cancer. Gynecol Oncol. 2019 May;153(2):425-435. doi: 10.1016/j.ygyno.2019.03.002. Epub 2019 Mar 7.
- Background: PubMed 31943158Lopez-Plana A, Fernandez-Nogueira P, Munoz-Guardiola P, Sole-Sanchez S, Megias-Roda E, Perez-Montoyo H, Jauregui P, Yeste-Velasco M, Gomez-Ferreria M, Erazo T, Ametller E, Recalde-Percaz L, Moragas-Garcia N, Noguera-Castells A, Mancino M, Moran T, Nadal E, Alfon J, Domenech C, Gascon P, Lizcano JM, Fuster G, Bragado P. The novel proautophagy anticancer drug ABTL0812 potentiates chemotherapy in adenocarcinoma and squamous nonsmall cell lung cancer. Int J Cancer. 2020 Aug 15;147(4):1163-1179. doi: 10.1002/ijc.32865. Epub 2020 Feb 6.
- Background: PubMed 33588149Vidal L, Victoria I, Gaba L, Martin MG, Brunet M, Colom H, Cortal M, Gomez-Ferreria M, Yeste-Velasco M, Perez A, Rodon J, Sohal DPS, Lizcano JM, Domenech C, Alfon J, Gascon P. A first-in-human phase I/Ib dose-escalation clinical trial of the autophagy inducer ABTL0812 in patients with advanced solid tumours. Eur J Cancer. 2021 Mar;146:87-94. doi: 10.1016/j.ejca.2020.12.019. Epub 2021 Feb 12.
- Background: PubMed 32943619Paris-Coderch L, Soriano A, Jimenez C, Erazo T, Munoz-Guardiola P, Masanas M, Antonelli R, Boloix A, Alfon J, Perez-Montoyo H, Yeste-Velasco M, Domenech C, Roma J, Sanchez de Toledo J, Moreno L, Lizcano JM, Gallego S, Segura MF. The antitumour drug ABTL0812 impairs neuroblastoma growth through endoplasmic reticulum stress-mediated autophagy and apoptosis. Cell Death Dis. 2020 Sep 17;11(9):773. doi: 10.1038/s41419-020-02986-w.
- Background: PubMed 36408162Mancini A, Colapietro A, Cristiano L, Rossetti A, Mattei V, Gravina GL, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Domenech C, Festuccia C. Anticancer effects of ABTL0812, a clinical stage drug inducer of autophagy-mediated cancer cell death, in glioblastoma models. Front Oncol. 2022 Nov 2;12:943064. doi: 10.3389/fonc.2022.943064. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carles Domènech, PhD study director
Ability Pharmaceuticals SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABTL0812 and Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Ability Pharmaceuticals SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergent Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417921, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.