ALE.P02 for Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Alentis Therapeutics AG
Must not be taking: QT drugs
Disqualifiers: Non-squamous cancers, Uncontrolled diabetes, CNS metastases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that you cannot use drugs that affect heart rhythm (QT interval). It's best to discuss your current medications with the trial team.
Eligibility Criteria
Adult patients with certain types of squamous solid tumors, including esophageal, skin, lung, head and neck, and cervical cancers that express a specific protein called CLDN1. Specific eligibility details are not provided.Inclusion Criteria
I am fully active or restricted in physically strenuous activity but can do light work.
I have recovered from side effects of my previous cancer treatments.
Have measurable disease based on RECIST 1.1 as determined by the site
+5 more
Exclusion Criteria
My cancer is mainly non-squamous, like adenocarcinoma.
I have received cancer treatment before this study within the given time frame.
My diabetes is not under control.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Phase I Dose Escalation
Patients receive ALE.P02 as monotherapy via intravenous infusion at escalating doses to determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE).
Up to 28 days
Phase I Dose Expansion
Patients receive ALE.P02 at the safe recommended dose to identify the Recommended Phase II Dose (RP2D).
Up to 3.5 years
Phase II
Patients receive ALE.P02 as monotherapy at the RP2D to assess anti-tumor activity.
Up to 3.5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment.
30 days
Participant Groups
The trial is testing ALE.P02 as a single treatment to see how safe it is and how well people tolerate it. It also looks at how the body processes the drug, its effects on tumors, and to find the best dose for Phase II trials.
3Treatment groups
Experimental Treatment
Group I: Phase II- ALE.P02Experimental Treatment1 Intervention
Patients will receive ALE.P02 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.
Group II: Phase I Dose Expansion- ALE.P02Experimental Treatment1 Intervention
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study to identify Recommended Phase II Dose (RP2D) for Phase II.
Group III: Phase I Dose Escalation- ALE.P02Experimental Treatment1 Intervention
Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Phase I dose escalation part of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NEXT Oncology VirginiaFairfax, VA
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Who Is Running the Clinical Trial?
Alentis Therapeutics AGLead Sponsor
References
Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology. [2018]Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a 'reviewer form' has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6-14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete 'ready-to-use' tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.
Performance of a Trigger Tool for Identifying Adverse Events in Oncology. [2021]Although patient safety is a priority in oncology, few tools measure adverse events (AEs) beyond treatment-related toxicities. The study objective was to assemble a set of clinical triggers in the medical record and assess the extent to which triggered events identified AEs.
Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma. [2021]Background Toxicity of oncology treatments in real-life patients is frequently disregarded and hence underreported. Objective To characterize adverse events (AEs) of immunotherapy and targeted therapy reported in patients with locally advanced or metastatic melanoma. Setting District Hospital for Cancer treatment (Instituto Português de Oncologia de Lisboa Francisco Gentil). Method A retrospective cohort of melanoma patients was established, comprising adult patients diagnosed with malignant melanoma treated with immunotherapy or targeted therapy. Exposure was characterized by nature, time and intensity of exposure. To account for different exposure periods, person-time was used as unit of analysis. Main outcomes measure Occurrence of AEs. Results Data from 111 patients included in the cohort indicates the majority received immunotherapy regimens (CTLA-4, anti-PD-1 and combination therapy; (n = 70; 63.1%), among which anti-PD-1 were the predominant treatment. Pembrolizumab was the most frequently prescribed drug (n = 30; 45.7%). Three hundred and seventy-one AEs were extracted. The incidence of AEs was lower in the anti-PD-1 mAc group (54 AEs per 1000 person.months) and the number of AEs/patient was also lower (3.1 ± 2.0). Grade 3 to 4 AEs occurred in 15.3% (n = 17) of the cohort, being more common in the targeted therapy group. Forty-two (11.6%) of the extracted AEs were not described in the Summary of Product Characteristics of the drugs under study. Conclusion This study suggests various known and unknown AEs of immunotherapy and targeted therapy may be identified using the Cancer Registry database. These events should be considered as signals worth further investigation for assessment of causality as the underreporting of AEs in cancer may have potential implications for the patient's quality of life.
Aggregated adverse-events outcomes in oncology phase III reports: A systematic review. [2018]Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership.
[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]Programmed cell death protein 1 (PD-1) combined with platinum containing dual drug chemotherapy is a new adjuvant treatment option for operable stage III non-small cell lung cancer (NSCLC), and the quality assurance of clinical trials of related drugs plays a crucial role in the results of the clinical trials. This study aims to explore the impact of adverse events (AEs) supervision on reducing treatment-related AEs in patients.