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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group performance status (ECOG PS) with no deterioration over the previous 2 weeks.

Progressive cancer at the time of enrollment.

Adequate organ and marrow function.

Must have evaluable disease.

Disqualifiers

Major surgery within 4 weeks of the first dose of study intervention.

Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study intervention.

With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention.

Any known history of persisting severe pancytopenia due to any cause.

Trial design

Treatments tested in this trial

  • AZD9574
  • Temozolomide (TMZ)
  • [11C]AZ1419 3391
  • Trastuzumab Deruxtecan (T-DXd)
  • Datopotamab Deruxtecan (Dato-DXd)

Treatment groups

695 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Locations

32
Australia
Research Site2010, Darlinghurst Australia
Research Site3000, Melbourne Australia
Research Site2031, Randwick Australia
Germany
Research Site80337, Bayern Germany

Sponsors and collaborators

AstraZeneca

Lead sponsor