Relapsed/Refractory Classical Hodgkin Lymphoma
Conditions
Brief summary
Part A Dose Escalation: Incidence of AEs, imAEs, and SAEs Incidence of AEs leading to discontinuation of sabestomig Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results Incidence of dose-limiting toxicities, Part B Dose Expansion (all): Incidence of AEs, imAEs, and SAEs Incidence of AEs leading to discontinuation of sabestomig Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results, Part B Dose Expansion (B1): Objective Response Rate (defined as the proportion of patients with complete remission or partial remission), Part B Dose Expansion (B2): Complete Response Rate (defined as the proportion of patients with complete remission)
Detailed description
Part A Dose Escalation: Complete Response Rate, Objective Response Rate, DoR, and DoCR and PFS including landmarks at 12 and 24 months OS including landmarks at 12 and 24 months, Part B Dose Expansion: DoR, DoCR and PFS including landmarks at 12 and 24 months OS including landmarks at 12 and 24 months Proportion of dosed subjects over time with: diarrhea, rash, and fatigue (PRO-CTCAE or Peds-PROCTCAE) overall side-effect bother (PGI-TT) quality of life/health (EORTC ILXX QL2), Part A Dose Escalation and Part B Dose Expansion: PK parameters including the maximum observed concentration, area under the concentration-time curve, clearance and terminal elimination half life • Incidence of anti-drug antibodies against sabestomig in serum
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Dose Escalation: Incidence of AEs, imAEs, and SAEs Incidence of AEs leading to discontinuation of sabestomig Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results Incidence of dose-limiting toxicities, Part B Dose Expansion (all): Incidence of AEs, imAEs, and SAEs Incidence of AEs leading to discontinuation of sabestomig Changes from baseline and clinically significant alterations in vital signs, laboratory parameters, and ECG results, Part B Dose Expansion (B1): Objective Response Rate (defined as the proportion of patients with complete remission or partial remission), Part B Dose Expansion (B2): Complete Response Rate (defined as the proportion of patients with complete remission) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A Dose Escalation: Complete Response Rate, Objective Response Rate, DoR, and DoCR and PFS including landmarks at 12 and 24 months OS including landmarks at 12 and 24 months, Part B Dose Expansion: DoR, DoCR and PFS including landmarks at 12 and 24 months OS including landmarks at 12 and 24 months Proportion of dosed subjects over time with: diarrhea, rash, and fatigue (PRO-CTCAE or Peds-PROCTCAE) overall side-effect bother (PGI-TT) quality of life/health (EORTC ILXX QL2), Part A Dose Escalation and Part B Dose Expansion: PK parameters including the maximum observed concentration, area under the concentration-time curve, clearance and terminal elimination half life • Incidence of anti-drug antibodies against sabestomig in serum | — |
Countries
Denmark, France, Italy, Spain