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 (PARTHENON)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524171-22-00

Enrollment

Registered

2026-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-20

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

Conditions

Solid Tumors

Brief summary

For Part A (Dose Escalations) and Part B (Dose Expansion): • Incidence (%) of DLTs (for Part A only). • Incidence of AEs/SAEs (%). • Changes from baseline in physical examination, vital signs, ECGs, and laboratory findings. For Part B (Dose Expansion) Only:Radiological response evaluated according to RECIST v1.1 • PFS

Detailed description

Efficacy: Radiological response evaluated according to RECIST v1.1 as described in the protocol. PK: Plasma concentrations of AZD4956 and plasma PK parameters, Urine PK parameters of AZD4956, as data permits. PD: Assessment of biomarker in tumour cells at baseline and during treatment., Module 2: PK: Plasma concentrations of saruparib and plasma PK parameters, including but not limited to AUC, Cmax, and tmax as data allow

Interventions

DRUGAZD4956

DRUGSaruparib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
For Part A (Dose Escalations) and Part B (Dose Expansion): • Incidence (%) of DLTs (for Part A only). • Incidence of AEs/SAEs (%). • Changes from baseline in physical examination, vital signs, ECGs, and laboratory findings. For Part B (Dose Expansion) Only:Radiological response evaluated according to RECIST v1.1 • PFS	—

Secondary

Measure	Time frame
Efficacy: Radiological response evaluated according to RECIST v1.1 as described in the protocol. PK: Plasma concentrations of AZD4956 and plasma PK parameters, Urine PK parameters of AZD4956, as data permits. PD: Assessment of biomarker in tumour cells at baseline and during treatment., Module 2: PK: Plasma concentrations of saruparib and plasma PK parameters, including but not limited to AUC, Cmax, and tmax as data allow	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 21, 2026