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

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

First listed

Jun 14, 2022

Start date

Jun 24, 2022

Status verified

Jul 2026

Primary completion

Nov 1, 2027

Completion

Nov 1, 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

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]
• AstraZeneca Breast Cancer Study Locator Service
  1-877-400-4656
  [email protected]

Locations (11)

Find similar trials in La Jolla, CA

Related Studies

• Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
  PHASE1/PHASE2 · Recruiting · Georgiamune Inc · Los Angeles, California
• A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
  PHASE1/PHASE2 · Recruiting · Bristol-Myers Squibb · Baltimore, Maryland