A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Conditions

• ER+ HER2- Advanced Breast Cancer
• High-grade Serous Ovarian Cancer (HGSOC)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AZD8421 — DRUG
  CDK2 inhibitor
• Camizestrant — DRUG
  SERD
• Ribociclib — DRUG
  CDK4/6 inhibitor
• Palbociclib — DRUG
  CDK4/6 inhibitor
• Abemaciclib — DRUG
  CDK4/6 inhibitor

Study Details

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

Key Dates

Start date

Dec 5, 2023

Status verified

May 2026

Primary completion

Aug 4, 2027

Completion

Aug 4, 2027

Study Design

Enrollment

564 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Module 1
  AZD8421 monotherapy
• Experimental: Module 2A
  AZD8421 with camizestrant and CDK4/6 inhibitor

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) as defined in the protocol. [ Time Frame: From start of treatment until the end of DLT period, assessed up to 28 days. ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (4)

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