A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy or in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors

ClinicalTrials.gov ID

NCT06747585

Acronym / sponsor ID

ALE.P02.01

Conditions

Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma

Keywords

Claudin-1 Targeted Antibody-Drug Conjugate, Monotherapy, First-in-Human, Recommended Phase 2 dose, Recommended dose for expansion, Combination therapy, Pembrolizumab, Anti-PD-1

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Recruiting

Enrolment

235 participants (estimated)

Lead sponsor

Alentis Therapeutics AGIndustry (pharma, biotech, devices)

Study start

16 Dec 2024 (actual)

Primary completion

15 Feb 2028 (estimated)

Study completion

15 Aug 2028 (estimated)

First posted

24 Dec 2024 (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.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Sequential

Masking

None (open label)

Number of arms

5

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Patients with Dose Limiting Toxicities (DLTs)

   Time frame: Up to 28 days

   DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P02 as a monotherapy or in combination with pembrolizumab (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).

2. Number of Patients with Adverse Events

   Time frame: Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 years])

   Adverse events will be assessed to evaluate safety and tolerability of ALE.P02 as a monotherapy or in combination with pembrolizumab (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).

3. Overall Response Rate (ORR) (Phase I)

   Time frame: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)

   The ORR is the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) This is assessed to establish RP2D for ALE.P02 (Phase I RDE)

4. Duration of Response (DoR) (Phase I)

   Time frame: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)

   The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR per Investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P02 (Phase I RDE).

5. Overall Response Rate (ORR) (Phase II)

   Time frame: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)

   The ORR is assessed to assess evaluate anti-tumor activity of ALE.P02 as a monotherapy (Phase II).

6. Duration of Response (DoR) (Phase II)

   Time frame: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)

   The DoR is assessed to evaluate assess anti-tumor activity of ALE.P02 as a monotherapy (Phase II).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.

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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.

41 sites in 8 countries: see every site and its status.