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

Part of paid clinical trials in New York, New York.

Sponsor
AstraZeneca
Study ID
NCT07446855
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD4956 — DRUG
    AZD4956 will be administered orally.
  • Saruparib — DRUG
    Saruparib will be administered orally.

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
May 2026
Primary completion
Mar 29, 2030
Completion
Mar 29, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Part A: AZD4956 monotherapy (Dose escalation)
    Participants will receive AZD4956 as monotherapy at ascending dose levels.
  • Experimental: Module 2 Part A: AZD4956 + saruparib (Dose escalation)
    Participants will receive AZD4956 at ascending dose levels in combination with saruparib.
  • Experimental: Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib
    Participants will receive AZD4956 in combination with saruparib.
  • Experimental: Module 2 Part A Optional PD backfill cohort: Saruparib monotherapy
    Participants will receive saruparib monotherapy.
  • Experimental: Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib
    Participants with metastatic castrate resistant prostate cancer (mCRPC) will receive AZD4956 in combination with saruparib.
  • Experimental: Module 2 Part B: AZD4956 + saruparib (Dose expansion)
    Participants will receive AZD4956 in combination with saruparib.

Primary Outcome Measure

Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From Screening (Day -28) to follow-up (up to 3.5 years) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteNew YorkNew York10065-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-

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