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RecruitingLast updated: 14 May 2024

This phase I/II study is evaluating how safe, tolerable and effective a new cancer drug (AZD8205) is in people with advanced or metastatic solid cancersA Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies

Clinical summary


This study has two parts. Part A (dose escalation) seeks to determine the safety, and what the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of AZD8205 is. All participants will receive AZD8205 alone. Part B (dose expansion) aims to evaluate the anti-cancer effectiveness of AZD8205. Participants with select solid cancers will receive AZD8205 as alone.

This trial is currently only recruiting Endometrial and Ovarian cancer patients.

It will soon commence recruitment for patients with Cholangiocarcinoma and Biliary Tract cancer. 


This trial is treating patients with breast cancer, ovarian cancer, bile duct cancer and endometrial cancer


Multi-Cancer Multi-Cancer





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Trial Identifiers

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Trial sponsor


Scientific Title

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies



  • Age ≥ 18 years
  • Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy.
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate organ and marrow function as defined in the protocol

For Sub-Study 1 Part A:

• Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer

For Sub-Study 1 Part B:

  • Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:

    1. Cohort B1 (Biliary Tract Cancer)
    2. Cohort B2 (Ovarian Cancer)
    3. Cohort B3 (Breast Cancer)
    4. Cohort B4 (Endometrial Cancer)


  • Treatment with any of the following:

    1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
    2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment
    3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:

      1. Cytotoxic treatment: 21 days
      2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
      3. Biological products including immuno-oncology agents: 28 days
  • Spinal cord compression or a history of leptomeningeal carcinomatosis.
  • Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study.
  • Active infection including tuberculosis and HBV, HCV or HIV
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Participants with any of the following cardiac criteria:

    1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.
    2. Uncontrolled hypertension.
    3. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.
    4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
    5. Symptomatic heart failure (NYHA class ≥ 2).
    6. Prior or current cardiomyopathy.
    7. Severe valvular heart disease.
    8. Mean resting QTcF > 470 msec.
    9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.


  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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