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Testing AZD8205 for advanced solid tumors alone or with other cancer drugs

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

Phase1; Phase2 Interventional AstraZeneca · NCT05123482

This study is testing a new cancer drug called AZD8205, either by itself or with other treatments, to see how safe and effective it is for people with advanced solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionstrastuzumab, immunotherapy, prednisone
Locations67 sites (Duarte, California and 66 other locations)
Trial IDNCT05123482 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of AZD8205, an antibody drug conjugate, in patients with advanced or metastatic solid tumors. It is designed as a Phase I/IIa multi-center, open-label study that includes dose escalation and expansion phases. Participants may receive AZD8205 alone or in combination with other anticancer agents, such as AZD2936 and AZD5305. The study aims to determine the optimal dosing and therapeutic potential of AZD8205 in various cancer types.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or metastatic solid tumors who have previously received standard care.

Not a fit: Patients with untreated solid tumors or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: Other studies involving antibody drug conjugates have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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 bone marrow, hepatic, and renal function as defined in the protocol

Additional Inclusion Criteria For Sub-Study 1 Part A:

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

Additional Inclusion Criteria 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)
  5. Cohort B5 (Squamous Non-Small Cell Lung Cancer)

     Additional Inclusion Criteria For Sub-Study 2 Part A:
* Minimum body weight ≥ 30 kg.
* Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.

Additional Inclusion Criteria For Sub-Study 3 Part A:

* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).
* Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.

Additional Inclusion Criteria For Sub-Study 4 Part A:

* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).
* Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, endometrial cancer or squamous non-small cell lung cancer.
* Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the Investigator.

Key Exclusion Criteria:

* 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.
* Patients with history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation)

Additional Exclusion Criteria For Sub-Study 2 Part A:

* Thromboembolic event within 3 months before the first dose of study intervention - No longer applicable per amendment 7
* Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* History of organ transplant

Additional Exclusion Criteria For Sub-Study 2 Part B

• Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)

Additional Exclusion Criteria For Sub-Study 3 Part A:

* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers/inhibitors.
* Any history of persisting (\> 2 weeks) severe cytopenia due to any cause
* Patients with any known predisposition to bleeding
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.
* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)

Additional Exclusion Criteria For Sub-Study 4 Part A:

* Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen
* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers/inhibitors.
* Previous treatment with rilvegostomig for the cohort treated with rilvegostomig
* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574

Where this trial is running

Duarte, California and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerBiliary Tract CarcinomaOvarian CancerEndometrial CancerSquamous Non-Small Cell Lung CancerFirst In Human, antibody drug conjugate, cancer, solid tumour, Phase I, Phase IIa
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.