Study identifier:D9571C00001
ClinicalTrials.gov identifier:NCT05216835
EudraCT identifier:2021-003569-36
CTIS identifier:N/A
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.
Relapsed or Refractory Classical Hodgkin Lymphoma
Phase 1/2
No
Sabestomig (AZD7789)
All
45
Interventional
16 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort A: Dose Escalation Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D). | Drug: Sabestomig (AZD7789) Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. |
Experimental: Cohort B1: Dose Expansion Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined. | Drug: Sabestomig (AZD7789) Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. |
Experimental: Cohort B2: Dose Expansion Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive sabestomig once the RP2D has been determined. | Drug: Sabestomig (AZD7789) Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. |