Advanced or Metastatic Squamous Solid Tumors
Conditions
Brief summary
Incidence of DLTs, Incidence and severity of AEs, SAEs, Clinically significant changes in laboratory values, vital signs, and electrocardiograms, Tolerability: dose interruptions and dose intensity, Preliminary efficacy parameters per RECIST 1.1: • ORR defined as CR rate + PR rate • DoR: duration of response Note: CLDN1 and indication subgroup analysis will also be performed, ORR defined as CR rate + PR rate per RECIST 1.1, DoR: duration of response Note: CLDN1 and indication subgroup analysis will also be performed
Detailed description
DCR defined as CR rate + PR rate + SD rate per RECIST 1.1, Median PFS (and rate at 6 and 12 months) per RECIST 1.1, Median OS and rate of 6-month, 12-month, and 24-month survival, Blood concentration: concentration of ALE.P02 ADC, total antibody and MMAE (payload), PK parameters including, but not limited to AUCtau, AUClast, AUCinf, Cmax, Cmin, Ctrough, Kel, t ½, Tmax, Cavg and other parameters as appropriate for ALE.P02 ADC, total antibody and MMAE, Presence of anti-ALE.P02 antibodies with screening and confirmatory assay, as appropriate, Incidence and severity of AEs and SAEs, Clinically significant changes in laboratory values, vital signs, and electrocardiograms, Tolerability: dose interruptions and dose intensity
Interventions
None listed
Sponsors
Alentis Therapeutics AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLTs, Incidence and severity of AEs, SAEs, Clinically significant changes in laboratory values, vital signs, and electrocardiograms, Tolerability: dose interruptions and dose intensity, Preliminary efficacy parameters per RECIST 1.1: • ORR defined as CR rate + PR rate • DoR: duration of response Note: CLDN1 and indication subgroup analysis will also be performed, ORR defined as CR rate + PR rate per RECIST 1.1, DoR: duration of response Note: CLDN1 and indication subgroup analysis will also be performed | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR defined as CR rate + PR rate + SD rate per RECIST 1.1, Median PFS (and rate at 6 and 12 months) per RECIST 1.1, Median OS and rate of 6-month, 12-month, and 24-month survival, Blood concentration: concentration of ALE.P02 ADC, total antibody and MMAE (payload), PK parameters including, but not limited to AUCtau, AUClast, AUCinf, Cmax, Cmin, Ctrough, Kel, t ½, Tmax, Cavg and other parameters as appropriate for ALE.P02 ADC, total antibody and MMAE, Presence of anti-ALE.P02 antibodies with screening and confirmatory assay, as appropriate, Incidence and severity of AEs and SAEs, Clinically significant changes in laboratory values, vital signs, and electrocardiograms, Tolerability: dose interruptions and dose intensity | — |
Countries
France, Italy, Spain
Outcome results
None listed