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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
Led by AstraZeneca · Updated on 2026-05-11
564
Participants Needed
14
Research Sites
191 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Participants with advanced solid tumors who have received prior adequate therapy according to local practice or when a clinical study is the best next treatment option
- Metastatic or locoregionally recurrent disease with evidence of progression after the last systemic therapy before starting study treatment
- ECOG/WHO performance status of 0 to 1 and life expectancy of at least 12 weeks
- At least one measurable or non-measurable lesion suitable for repeated assessment at baseline according to RECIST v1.1
You will not qualify if you...
- Received cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs within 14 days or 5 half-lives before the first dose of study drug (21 days for myelosuppressive therapies), except GnRHa and bone-stabilizing agents
- Use of drugs known to strongly affect CYP3A4/5 that cannot be stopped before and during the study until 2 weeks after last dose
- Use of drugs with risk of Torsades de Pointes
- Radiotherapy for palliation within 1 week before the first dose
- Major surgery or significant trauma within 4 weeks before the first dose, or planned major surgery during the study
- Unresolved side effects of Grade 2 or higher from prior cancer therapy, except stable Grade 2 neuropathy
- Life-threatening metastatic visceral disease or uncontrolled CNS metastases, except treated and stable spinal cord compression or brain metastases
- Severe or uncontrolled systemic diseases including uncontrolled hypertension and active infections requiring IV antibiotics
- Cardiac issues including QTcF > 470 msec, significant ECG abnormalities, symptomatic heart failure, or recent major cardiac events
- Inadequate bone marrow or organ function
- Gastrointestinal conditions affecting drug absorption
- Allergy to AZD8421 or similar drugs
- Previous treatment with AZD8421 or similar kinase inhibitors
- Currently pregnant, breastfeeding, or planning pregnancy; must agree to use effective contraception if of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Research Site
St Louis, Missouri, United States, 63141
Actively Recruiting
2
Research Site
Providence, Rhode Island, United States, 02903
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3
Research Site
Nashville, Tennessee, United States, 37201
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4
Research Site
Houston, Texas, United States, 77030
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5
Research Site
East Melbourne, Australia, 3002
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6
Research Site
Seoul, South Korea, 03722
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7
Research Site
Seoul, South Korea, 06351
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8
Research Site
Barcelona, Spain, 8035
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9
Research Site
Pamplona, Spain, 31005
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10
Research Site
Valencia, Spain, 46010
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11
Research Site
Cambridge, United Kingdom, CB2 0XY
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12
Research Site
Leeds, United Kingdom, LS9 7TF
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13
Research Site
London, United Kingdom, EC1A 7BE
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14
Research Site
Manchester, United Kingdom, M20 4BX
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Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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