A Phase I/II, Open-Label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Solid Tumors

Condition studied

Advanced or Metastatic Solid Tumors

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 1: Incidence of DLTs, Phase 1: Incidence and severity of AEs and SAEs, Phase 1: Clinically significant changes in laboratory values, vital signs, and ECGs, Phase 1: Tolerability: dose interruptions and dose intensity, Phase 1: Preliminary efficacy parameters per RECIST 1.1 (see protocol for further details): o ORR (defined as CR rate + PR rate) o DoR Note: CLDN1 expression and tumor type subgroup analyses may be performed for these endpoints., Phase 2: Efficacy parameters per RECIST 1.1*: • ORR • DoR Note: CLDN1 expression and tumor type subgroup analyses may be performed for these endpoints.

Endpoint detail

Incidence and severity of AEs and SAEs, Clinically significant changes in laboratory values, vital signs, and ECGs, Tolerability: dose interruptions and dose intensity, DCR per RECIST 1.1 (see protocol for further details), Median PFS (and rate at 6 and 12 months) per RECIST 1.1 (see protocol for further details), Median OS and rate of 6-, 12-, and 24-month survival Note: CLDN1 expression and tumor type subgroup analyses may be performed for these endpoints., PK: • Plasma concentration of ALE.P03 ADC (including total antibody, conjugated exatecan, and free payload exatecan) by cohort PK parameters including, but not limited to, AUCtau, AUClast, AUC0-inf, Cmax, Cmin, Ctrough, Kel, t½, tmax, Cavg, and other parameters as appropriate for total antibody, conjugated exatecan, and free payload exatecan for each dose level and cycle as supported by available data, Immunogenicity: • Presence of anti-ALE.P03 antibodies with screening and confirmatory assay, as appropriate • Proportion of patients categorized by ADA status (ADA positive/negative) following confirmatory assay