Endometrial CancerPhase 1/2EndolungNCT03366480
A Study to Assess the Efficacy and Safety of ABTL0812
A Phase 1/2 study testing ABTL0812 in combination with paclitaxel and carboplatin in people with Endometrial Cancer and Squamous Non-Small Cell Lung Cancer, run by Ability Pharmaceuticals SL at 1 site in Spain.
Trial summary
A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer, Squamous Non-Small Cell Lung Cancer
- What is being tested?
- ABTL0812 in combination with paclitaxel and carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2016to 15 Nov 2020
- 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
- For endometrial cancer: Patients with advanced, metastatic or recurrent endometrial cancer, from all histological types except carcinosarcoma and leiomyosarcoma.
- For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non-irradiance IIIb stage or stage IV), excluding mixed tumors, neuroendocrine or adenocarcinoma.
- Have adequate tumor tissue available (either archival not older than 6 months 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
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- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- 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.
- Adequate bone marrow function defined as:
- absolute neutrophil count ≥ 1.5x109/L
- platelet count ≥ 100x109/L
- hemoglobin ≥ 10.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal
- Aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤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)
- Glomerular filtration rate ≥ 50 mL/min
- Serum creatinine ≤1.5 ULN
- 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 4.02).
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
Who cannot join
- Patients previously treated with an inhibitor of the Phosphoinositide 3-kinase/Protein kinase B/mechanistic target of rapamycin (PI3K/Akt/mTOR) pathway.
- Patients previously treated with adjuvant or co-adjuvant chemotherapy administered 6 months or less in advance of patient inclusion
- Patients with symptomatic brain metastases. Patients with asymptomatic and treated 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 with 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 with 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.
Show all 9Show fewer
- Evidence of pre-existing uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Patients with 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 Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC
A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC.
Read the detailed description
This is a phase I/II multicenter divided in two phases.
Phase I: Safety and dose escalation
This study is not randomized, and all included patients will receive ABTL0812 in addition to paclitaxel + carboplatin (SOC). In this phase, patients can be selected from both indications, regardless of the number of each indication.
This phase will be divided in 2 periods:
Period 1:
A dose de-escalation phase will be performed with a 3 + 3 design, in which up to four different ABTL0812 dose levels will be tested in combination with SOC. Then, 12 patients will be included in an expansion phase. All patients will receive one week of ABTL0812 alone followed by ABTL0812 + SOC (up to 8 SOC cycles) as combined treatment.
Period 2:
After the finalization of the SOC cycles, ABTL0812 will be taken as single therapy, at 1300 mg tid, up to 12 months from initiation of period 1. This is the Recommended Phase 2 Dose (RP2D) as monotherapy for ABTL0812 determined in the previous phase I clinical trial.
Phase II: Efficacy and safety
This phase of the study will include up to 33 patients per indication (up to 66 patients overall). The final number will depend on the number of patients included in the phase I. The number of patients selected per indication will depend on the number already selected in phase I, as it is necessary to compensate both indications to have a final number of 40 patients per indication approximately.
- Being tested
- ABTL0812 in combination with paclitaxel and carboplatin
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTL0812 in combination with paclitaxel and carboplatinDrug
ABTL0812 in combination with paclitaxel and carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer | Experimental | ABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with advanced endometrial cancer, up to 12 months from initiation. Receives: Drug: ABTL0812 in combination with paclitaxel and carboplatin |
| Squamous non-small cell lung cancer | Experimental | ABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with squamous NSCLC, up to 12 months from initiation. Receives: Drug: ABTL0812 in combination with paclitaxel and carboplatin |
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
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
Measured: 2 years
Progression Free Survival (PFS)
Progression Free Survival (PFS) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
Measured: 2 years
Time to Progression (TP)
Time to Progression (TP) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
Measured: 2 years
Duration of Response (DR)
Duration of Response (DR), based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Dec 2016
- Primary completion1 Jun 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endometrial 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ability Pharmaceuticals SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron, Institut Català d'Oncologia, Hospital Clínico Universitario de Valencia, Hospitales Universitarios Virgen del Rocío, Centre Leon Berard, Institut Paoli-Calmettes, Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Ana Oaknin, Principal investigator, VHIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366480
- Sponsor's protocol ID
- ABT-C5-2016
- Other IDs
- 2016-001352-21, 2016
- Acronym
- Endolung
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2017
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36408162Leary A, Estevez-Garcia P, Sabatier R, Ray-Coquard I, Romeo M, Barretina-Ginesta P, Gil-Martin M, Garralda E, Bosch-Barrera J, Moran T, Martin-Martorell P, Nadal E, Gascon P, Rodon J, Lizcano JM, Munoz-Guardiola P, Fierro-Duran G, Pedros-Gamez O, Perez-Montoyo H, Yeste-Velasco M, Cortal M, Perez-Campos A, Alfon J, Domenech C, Perez-Fidalgo A, Oaknin A. ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer. BMC Cancer. 2024 Jul 22;24(1):876. doi: 10.1186/s12885-024-12501-5.
PubMed 39039449Polonio-Alcala E, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Lizcano JM, Domenech C, Ruiz-Martinez S, Puig T. ABTL0812 enhances antitumor effect of paclitaxel and reverts chemoresistance in triple-negative breast cancer models. Cancer Commun (Lond). 2022 Jun;42(6):567-571. doi: 10.1002/cac2.12282. Epub 2022 Mar 16. No abstract available.
PubMed 35293148
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC
- ClinicalTrials.gov ID
- NCT03366480
- Acronym / sponsor ID
- Endolung / ABT-C5-2016
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ability Pharmaceuticals SLIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron, Institut Català d'Oncologia, Hospital Clínico Universitario de Valencia, Hospitales Universitarios Virgen del Rocío, Centre Leon Berard, Institut Paoli-Calmettes, Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 8 Dec 2017 (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 phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC.
Detailed description
This is a phase I/II multicenter divided in two phases.
Phase I: Safety and dose escalation
This study is not randomized, and all included patients will receive ABTL0812 in addition to paclitaxel + carboplatin (SOC). In this phase, patients can be selected from both indications, regardless of the number of each indication.
This phase will be divided in 2 periods:
Period 1:
A dose de-escalation phase will be performed with a 3 + 3 design, in which up to four different ABTL0812 dose levels will be tested in combination with SOC. Then, 12 patients will be included in an expansion phase. All patients will receive one week of ABTL0812 alone followed by ABTL0812 + SOC (up to 8 SOC cycles) as combined treatment.
Period 2:
After the finalization of the SOC cycles, ABTL0812 will be taken as single therapy, at 1300 mg tid, up to 12 months from initiation of period 1. This is the Recommended Phase 2 Dose (RP2D) as monotherapy for ABTL0812 determined in the previous phase I clinical trial.
Phase II: Efficacy and safety
This phase of the study will include up to 33 patients per indication (up to 66 patients overall). The final number will depend on the number of patients included in the phase I. The number of patients selected per indication will depend on the number already selected in phase I, as it is necessary to compensate both indications to have a final number of 40 patients per indication approximately.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer | Experimental | Drug: ABTL0812 in combination with paclitaxel and carboplatinABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with advanced endometrial cancer, up to 12 months from initiation. |
| Squamous non-small cell lung cancer | Experimental | Drug: ABTL0812 in combination with paclitaxel and carboplatinABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with squamous NSCLC, up to 12 months from initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients ≥18 years of age
- Willing and able to provide informed consent
- For endometrial cancer: Patients with advanced, metastatic or recurrent endometrial cancer, from all histological types except carcinosarcoma and leiomyosarcoma.
- For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non-irradiance IIIb stage or stage IV), excluding mixed tumors, neuroendocrine or adenocarcinoma.
- Have adequate tumor tissue available (either archival not older than 6 months or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
Key exclusion criteria (9 listed)
- Patients previously treated with an inhibitor of the Phosphoinositide 3-kinase/Protein kinase B/mechanistic target of rapamycin (PI3K/Akt/mTOR) pathway.
- Patients previously treated with adjuvant or co-adjuvant chemotherapy administered 6 months or less in advance of patient inclusion
- Patients with symptomatic brain metastases. Patients with asymptomatic and treated 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 with 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.
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 |
|---|---|---|
| ABTL0812 in combination with paclitaxel and carboplatinABTL0812 in combination with paclitaxel and carboplatin. | Drug | Endometrial cancer, Squamous non-small cell lung cancer |
Primary outcome
Emergent Adverse Events
Time frame: 1 year
Related Adverse Events as Assessed by CTCAE v4.03
4 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Progression Free Survival (PFS)
Time frame: 2 years
Time to Progression (TP)
Time frame: 2 years
Duration of Response (DR)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- 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.
- Derived from this study: PubMed 39039449Leary A, Estevez-Garcia P, Sabatier R, Ray-Coquard I, Romeo M, Barretina-Ginesta P, Gil-Martin M, Garralda E, Bosch-Barrera J, Moran T, Martin-Martorell P, Nadal E, Gascon P, Rodon J, Lizcano JM, Munoz-Guardiola P, Fierro-Duran G, Pedros-Gamez O, Perez-Montoyo H, Yeste-Velasco M, Cortal M, Perez-Campos A, Alfon J, Domenech C, Perez-Fidalgo A, Oaknin A. ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer. BMC Cancer. 2024 Jul 22;24(1):876. doi: 10.1186/s12885-024-12501-5.
- Derived from this study: PubMed 35293148Polonio-Alcala E, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Lizcano JM, Domenech C, Ruiz-Martinez S, Puig T. ABTL0812 enhances antitumor effect of paclitaxel and reverts chemoresistance in triple-negative breast cancer models. Cancer Commun (Lond). 2022 Jun;42(6):567-571. doi: 10.1002/cac2.12282. Epub 2022 Mar 16. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Ana Oaknin principal investigator
VHIO
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 in combination with paclitaxel and carboplatin in people with Endometrial Cancer and Squamous Non-Small Cell Lung 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 20 inclusion and 9 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: finished, as of the sponsor's last update on 22 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT03366480, which also lists 9 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 22 Feb 2023.