ALE.P02 for Cancer

Recruiting at 12 trial locations

Overseen By Alentis Clinical Trial Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alentis Therapeutics AG

Must not be taking: QT drugs

Disqualifiers: Non-squamous cancers, Uncontrolled diabetes, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

170 Participants Needed

Trial Summary

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.

What safety data exists for ALE.P02 or similar treatments in humans?

The research articles provided do not contain specific safety data for ALE.P02 or similar treatments in humans. ^{1 2 3 4 5}

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.

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

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.

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

Treatment Details

Interventions

• ALE.P02

Trial Overview 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.

Participant Groups

Group I: Phase II- ALE.P02 Experimental Treatment 1 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.P02 Experimental Treatment 1 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.P02 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Alentis Therapeutics AG

Lead Sponsor

Trials

4

Recruited

310+

Findings from Research

A new oncology-focused trigger tool has been developed to systematically assess adverse drug events (ADEs) in cancer care, validated by a panel of 30 pharmacists and practitioners across nine hospitals in France.

The tool includes a standardized list of 15 specific ADEs, along with criteria for evaluating causality, severity, and preventability, making it a practical resource for monitoring and improving patient safety in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology. Hébert, G., Netzer, F., Kouakou, SL., et al.[2018]

A retrospective study involving 400 cancer patients identified 790 clinical triggers in medical records, leading to the detection of 304 unique adverse events (AEs), highlighting the tool's potential to improve patient safety in oncology.

The original screening tool had a positive predictive value (PPV) of 0.40 for total AEs and 0.15 for preventable AEs, with modifications increasing the PPV to 0.48 for total AEs, suggesting that refining this tool could enhance its effectiveness in real-time AE detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Trigger Tool for Identifying Adverse Events in Oncology. Lipitz-Snyderman, A., Classen, D., Pfister, D., et al.[2021]

In a study of 111 melanoma patients treated with immunotherapy or targeted therapy, the majority received immunotherapy, particularly anti-PD-1 treatments, with a total of 371 adverse events (AEs) reported.

The incidence of AEs was lower in patients receiving anti-PD-1 therapy, with only 15.3% experiencing severe (grade 3 to 4) AEs, which were more common in those on targeted therapies, highlighting the need for better reporting and understanding of both known and unknown AEs in cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma. Aguiar, JP., Cardoso Borges, F., Murteira, R., et al.[2021]

In a review of 325 randomized controlled trials (RCTs) in oncology published between 2007 and 2011, only 29% reported aggregated adverse events (A-AEs), indicating that their use is infrequent despite acceptance among clinicians.

Most studies (80%) did not provide a clear description of the A-AEs included, highlighting the need for better reporting standards to ensure important details about drug toxicities are communicated effectively to healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregated adverse-events outcomes in oncology phase III reports: A systematic review. Maillet, D., Gan, HK., Blay, JY., et al.[2018]

In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).

The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. Zhang, Y., Zhou, S., Tao, W., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a 'ready-to-use' tool that includes preventability, for the assessment of adverse drug events in oncology. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Performance of a Trigger Tool for Identifying Adverse Events in Oncology. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Aggregated adverse-events outcomes in oncology phase III reports: A systematic review. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]