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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06747585). This is a study registration, not published results. Lead sponsor: Alentis Therapeutics AG. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 235 participants (ESTIMATED). Conditions: Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma. Interventions: DRUG: ALE.P02; DRUG: Pembrolizumab. Primary outcome measures: Number of Patients with Dose Limiting Toxicities (DLTs) , Up to 28 days; Number of Patients with Adverse Events , Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 years]); Overall Response Rate (ORR) (Phase I) , From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years); Duration of Response (DoR) (Phase I) , From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years); Overall Response Rate (ORR) (Phase II) , From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years); Duration of Response (DoR) (Phase II) , From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years). Brief summary: 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 as a monotherapy or in combination with pembrolizumab in adult patients with selected squamous solid tumors.