Study identifier:D9570C00001
ClinicalTrials.gov identifier:NCT04931654
EudraCT identifier:2021-000036-57
CTIS identifier:2022-502774-17-00
A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors.
Carcinoma, Non-Small-Cell Lung
Phase 1/2
No
AZD7789
All
232
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance AZD7789 monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |
Experimental: Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1 AZD7789 Monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |
Experimental: Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1 AZD7789 Monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |
Experimental: Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2 AZD7789 Monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |
Experimental: Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1 AZD7789 monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |
Experimental: Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 AZD7789 monotherapy | Drug: AZD7789 anti-PD-1 and anti-TIM-3 bispecific antibody |