A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

ALE.P03: ALE.P03, will be administered by IV infusion according to the assigned arms.

ALE.P03: ALE.P03, will be administered by IV infusion according to the assigned arms.

ALE.P03: ALE.P03, will be administered by IV infusion according to the assigned arms.

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.P03 monotherapy in adult patients with selected squamous solid tumors.

Eligibility

Primary outcome measure(s)

• Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I) — Up to 28 days
  DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
• Number of Patients with Adverse Events (Phase I) — From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])
  Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
• Overall Response Rate (ORR) (Phase I) — From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 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.P03 (Phase I RDE)
• Duration of Response (DoR) (Phase I) — From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
  The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE).
• Overall Response Rate (ORR) (Phase II) — From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)
  The ORR is assessed to assess anti-tumor activity of ALE.P03 (Phase II).
• Duration of Response (DoR) (Phase II) — From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)
  The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to assess anti-tumor activity of ALE.P03 (Phase II).

Trial sites (41)

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

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