ALE.P02 for Cancer

Recruiting at 31 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALE.P02 for certain types of squamous solid tumors. The aim is to determine the safety and effectiveness of ALE.P02 against cancer that has returned or spread. The trial involves increasing the dose to find the optimal amount for future studies. Suitable candidates for this trial have specific types of advanced cancer, such as certain lung or head and neck cancers, and have not responded to one or two other treatments. Participants should have measurable tumors and should not have rapidly progressing disease or uncontrolled diabetes. As a Phase 1 trial, this research focuses on understanding how ALE.P02 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ALE.P02 is likely to be safe for humans?

Research has shown that ALE.P02 could be a promising treatment for certain types of cancer. The FDA granted ALE.P02 fast-track status, indicating it addresses an unmet medical need. While this is encouraging, it does not replace the need for comprehensive safety information.

Earlier studies focused on the safety of ALE.P02, aiming to determine a dose that minimizes side effects. Researchers are still learning about its safety in humans.

Since ALE.P02 remains in early testing, safety information is limited. These trials aim to identify the highest dose that can be taken without serious problems. So far, no major safety issues have been reported, but more data is needed. The goal is to find a dose that is both effective and safe for broader use in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Most treatments for cancer work by attacking rapidly dividing cells, which often leads to damage to healthy cells and significant side effects. ALE.P02 is unique because it targets a specific pathway involved in cancer cell growth, potentially offering a more precise attack on cancer cells while sparing normal cells. This precision could lead to fewer side effects and improved outcomes for patients. Researchers are excited about ALE.P02 because it represents a targeted therapy approach, which is a promising frontier in cancer treatment, aiming for effectiveness with less collateral damage.

What evidence suggests that ALE.P02 might be an effective treatment for cancer?

Research has shown that ALE.P02 targets claudin-1, a protein often found in large amounts in certain cancers, such as lung and head and neck cancers. This protein aids cancer cell growth and spread, so targeting it could help stop the cancer. Early findings suggest that ALE.P02 can kill cancer cells in these tumors by breaking down the barriers that protect them. The FDA has recognized its potential by granting it fast track status, indicating promise. While more information is needed, early results indicate potential for treating these difficult cancers. Participants in this trial will receive ALE.P02 as monotherapy, with the study progressing through different phases to determine the optimal dosing strategy. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06747585

A Study to Investigate ALE.P02 as Monotherapy in Adult ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the ...

2.

targetedonc.com

targetedonc.com/view/ale-p02-gains-fda-fast-track-status-in-cldn1-solid-tumors

ALE.P02 Gains FDA Fast Track Status in CLDN1+ Solid ...

ALE.P02, an anti-CLDN1 ADC, has been granted FDA fast track designation for the potential treatment of patients with CLDN1-positive squamous solid tumors.

3.

nature.com

nature.com/articles/d42473-023-00339-7

Claudin-1-targeted therapies break barriers in precision ...

Targeting claudin-1 offers a promising approach for treating solid tumours by selectively killing cancer cells and breaking down barriers to immunotherapy.

4.

alentis.ch

alentis.ch/alentis-therapeutics-receives-fda-ind-clearance-for-ale-p02-a-novel-cldn1-adc-for-the-treatment-of-squamous-cancers/

Alentis Therapeutics Receives FDA IND Clearance for ALE ...

“ALE.P02 is particularly promising for squamous cancers, including HNSCC and NSCLC, where CLDN1 is often overexpressed. The unmet medical need ...

5.

pharmacytimes.com

pharmacytimes.com/view/antibody-drug-conjugate-targeting-cldn1-receives-fda-fast-track-designation

Antibody Drug Conjugate Targeting CLDN1 Receives FDA ...

ALE.P02 could provide treatment for lung, head and neck, cervical, and esophageal CLDN1+ squamous cancers, but is not limited to additional ...

6.

alentis.ch

alentis.ch/ale-p02-ale-p03-adcs-for-claudin-1-positive-tumors/

ALE.P02 & ALE.P03 ADCs for Claudin-1 positive tumors

The FDA granted ALE. P02 Fast Track designation for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin.

7.

uchicagomedicine.org

uchicagomedicine.org/find-a-clinical-trial/clinical-trial/irb242139

CLINICAL TRIAL / NCT06747585

This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at ...

8.

clinicaltrials.eu

clinicaltrials.eu/trial/study-of-ale-p02-for-adults-with-advanced-or-metastatic-squamous-solid-tumors/

Study of ALE.P02 for Adults with Advanced or Metastatic ...

This treatment is being tested to see if it is safe and how well it works in people with certain advanced or spreading cancers that have this protein.