NCT07446855

Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours

A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumours with homologous recombination repair (HRR) deficiencies.

Detailed description

The study consists of individual modules each evaluating the safety and tolerability of AZD4956 dosed as monotherapy, or with a specific combination partner. There are following 2 modules - 1. Module 1: AZD4956 monotherapy 2. Module 2: AZD4956 in combination with saruparib Each module may further contain 2 parts- * Part A (dose escalation/dose finding): To determine the safety, tolerability, PK, PD, and preliminary efficacy of AZD4956 as monotherapy or in combination. * Part B (dose expansion): To further evaluate the safety and preliminary efficacy of AZD4956 in combination with other anti-cancer agents.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	AZD4956	AZD4956 will be administered orally.
DRUG	Saruparib	Saruparib will be administered orally.

Timeline

• Start date: 2026-03-17
• Primary completion: 2030-03-29
• Completion: 2030-03-29
• First posted: 2026-03-03
• Last updated: 2026-03-27

Locations

13 sites across 6 countries: United States, Australia, Japan, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study