Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT05417594
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Malignancies

Eligibility Criteria

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

Interventions

  • AZD9574 — DRUG
    Participants will receive AZD9574 orally.
  • Temozolomide (TMZ) — DRUG
    Participants will receive temozolomide orally.
  • [11C]AZ1419 3391 — DRUG
    Participants will receive \[11C\]AZ1419 3391 intravenously.
  • Trastuzumab Deruxtecan (T-DXd) — DRUG
    Participants will receive T-DXd intravenously.
  • Datopotamab Deruxtecan (Dato-DXd) — DRUG
    Participants will receive Dato-DXd intravenously.

Study Details

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

Key Dates

Start date
Jun 24, 2022
Status verified
May 2026
Primary completion
Oct 13, 2027
Completion
Oct 13, 2027

Study Design

Enrollment
695 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Part A: Dose escalation
    Participants with advanced/relapsed ovarian, breast, pancreatic, or prostate cancer who are deemed suitable for a PARPi will receive AZD9574 monotherapy at escalating cohorts.
  • Experimental: Module 1 Part B: Dose expansion
    Participants with breast cancer who are PARPi naive at doses determined in dose-escalation.
  • Experimental: Module 2 Part A: Dose escalation
    Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts.
  • Experimental: Module 3 Panel 1: AZD9574 monotherapy (Sweden only)
    Participants with advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm.
  • Experimental: Module 3 Panel 2: AZD9574 + TMZ (Sweden only)
    Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts.
  • Experimental: Module 3 Panel 3: AZD9574 monotherapy (Sweden only)
    Participants with breast cancer (without BM).
  • Experimental: Module 4 Part A: Dose escalation (AZD9574 + T-DXd)
    Participants with advanced, unresectable, or metastatic solid tumours that are HER2-positive will receive a combination of AZD9574 and T-DXd at at escalating cohorts.
  • Experimental: Module 4 Part B : Dose expansion (AZD9574 + T-DXd)
    Participants with HER2-low/ultralow, HR positive breast cancer will receive a combination of different doses of AZD9574 and T-DXd at expanding cohorts.
  • Experimental: Module 5 Part A : Dose escalation (AZD9574 + Dato-DXd)
    Participants with advanced, unresectable, or metastatic solid tumours in different types of cancers will receive a combination of AZD9574 and Dato-DXd at escalating cohorts.

Primary Outcome Measure

Incidence of Adverse Events (AEs), and Serious Adverse Events (SAEs) [ Time Frame: From first dose to post-treatment follow-up (approximately three years) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94143-
Research SiteChicagoIllinois60611-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10040-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97239-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-
Research SiteRichmondVirginia23298-

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