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

Condition(s) studied

Investigational drug(s) / intervention(s)

ALE.P02: ALE.P02 will be administered by IV infusion according to the assigned arms.

Pembrolizumab: Pembrolizumab will be administered per local labeling or institutional guidelines.

Study 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.

Eligibility

Primary outcome measure(s)

• Number of Patients with Dose Limiting Toxicities (DLTs) — 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).
• 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])
  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).
• 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)
  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)
• Duration of Response (DoR) (Phase I) — 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).
• 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)
  The ORR is assessed to assess evaluate anti-tumor activity of ALE.P02 as a monotherapy (Phase II).
• Duration of Response (DoR) (Phase II) — 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).

Trial sites (41)

+ 1 more sites — see the full list on the official registry below.

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