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)
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents
• 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:
‣ Cohort B1 (Biliary Tract Cancer)
⁃ Cohort B2 (Ovarian Cancer)
⁃ Cohort B3 (Breast Cancer)
⁃ Cohort B4 (Endometrial Cancer)
⁃ 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.