Locally Advanced or Metastatic Cancer, Unresectable
Conditions
Brief summary
For Dose Escalation : MTD/OBD and/or DLT during the DLT evaluation period and all serious adverse events, adverse events tabulated/reported by type, grade, and frequency for the entire study duration., For Cohort Expansion: • RP2D based on the totality of the data and primarily based on the ORR and AE & SAE. • ORR according to RECIST 1.1 (Eisenhauser 2009) or PCWG3 criteria (Scher 2016).
Detailed description
For dose Escalation : •PK (analysis of Cmax, AUC, Tmax, and t½ following treatment completion). • ADA status. • ORR according to standard RECIST 1.1 criteria (Eisenhauer 2009)., For Cohort Expansion: •Evaluate DoR, DCR, and PFS according to RECIST 1.1 (Eisenhauer 2009) or PCWG3 criteria (Scher 2016). • Evaluate emerging AEs/SAEs tabulated by tumor type. • PK (analysis of maximum observed drug concentration [Cmax], AUC, time to maximum observed drug concentration (Tmax), and terminal elimination half-life (t½) following treatment completion) evaluation by dose and tumor type.
Interventions
None listed
Sponsors
Salubris Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Dose Escalation : MTD/OBD and/or DLT during the DLT evaluation period and all serious adverse events, adverse events tabulated/reported by type, grade, and frequency for the entire study duration., For Cohort Expansion: • RP2D based on the totality of the data and primarily based on the ORR and AE & SAE. • ORR according to RECIST 1.1 (Eisenhauser 2009) or PCWG3 criteria (Scher 2016). | — |
Secondary
| Measure | Time frame |
|---|---|
| For dose Escalation : •PK (analysis of Cmax, AUC, Tmax, and t½ following treatment completion). • ADA status. • ORR according to standard RECIST 1.1 criteria (Eisenhauer 2009)., For Cohort Expansion: •Evaluate DoR, DCR, and PFS according to RECIST 1.1 (Eisenhauer 2009) or PCWG3 criteria (Scher 2016). • Evaluate emerging AEs/SAEs tabulated by tumor type. • PK (analysis of maximum observed drug concentration [Cmax], AUC, time to maximum observed drug concentration (Tmax), and terminal elimination half-life (t½) following treatment completion) evaluation by dose and tumor type. | — |
Countries
Belgium, Spain
Outcome results
None listed