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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502774-17-00

Acronym

D9570C00001

Enrollment

Registered

2024-05-31

Start date

2021-10-04

Completion date

2025-02-27

Last updated

2025-02-17

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

Conditions

Advanced or metastatic gastric and gastro-esophageal junction (GEJ) adenocarcinoma, Advanced or Metastatic Non-small Cell Lung Carcinoma, Advanced or Metastatic Solid Tumors

Brief summary

Adverse Events (AEs), imAEs, Serious Adverse Events (SAEs), and DLTs, AEs leading to discontinuation of AZD7789, Clinically significant alterations in vital signs, laboratory parameters, and ECG results, Part B Dose Expansion: Objective Response Rate (ORR) according to RECIST v1.1

Detailed description

For Dose Escalation: o ORR, Disease Control Rate (DCR), Duration of Response (DoR), and Progression-free Survival (PFS) according to RECIST v1.1, changes in ctDNA and Overall Survival (OS), For Dose Expansion: o DCR, DoR, PFS according to RECIST v1.1, changes in ctDNA and OS, For Dose Escalation and Expansion: o PK parameters including Cmax, AUC, clearance, and t 1/2, For Dose Escalation and Expansion: o Incidence of ADAs against AZD7789 in serum

Interventions

DRUGAZD7789

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse Events (AEs), imAEs, Serious Adverse Events (SAEs), and DLTs, AEs leading to discontinuation of AZD7789, Clinically significant alterations in vital signs, laboratory parameters, and ECG results, Part B Dose Expansion: Objective Response Rate (ORR) according to RECIST v1.1	—

Secondary

Measure	Time frame
For Dose Escalation: o ORR, Disease Control Rate (DCR), Duration of Response (DoR), and Progression-free Survival (PFS) according to RECIST v1.1, changes in ctDNA and Overall Survival (OS), For Dose Expansion: o DCR, DoR, PFS according to RECIST v1.1, changes in ctDNA and OS, For Dose Escalation and Expansion: o PK parameters including Cmax, AUC, clearance, and t 1/2, For Dose Escalation and Expansion: o Incidence of ADAs against AZD7789 in serum	—

Measure

Time frame

—

Countries

France, Netherlands, Spain

Outcome results

None listed

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