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A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502773-41-00
Acronym
D9571C00001
Enrollment
78
Registered
2024-02-28
Start date
2022-06-16
Completion date
2025-09-04
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Classical Hodgkin Lymphoma

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

DRUGPARACETAMOL
DRUGDIPHENHYDRAMINE
DRUGINFLIXIMAB
DRUGTOCILIZUMAB
DRUGEPINEPHRINE

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026