Clinical Trials List
2023-06-01 - 2027-12-31
Phase I/II
Recruiting5
ICD-10C69.40
Malignant neoplasm of unspecified ciliary body
ICD-10C69.41
Malignant neoplasm of right ciliary body
ICD-10C69.42
Malignant neoplasm of left ciliary body
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
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)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張淑涵 無
- Gigin Lin 無
- Angel Chao 無
- 董秀蓉 無
- 張宸斌 無
- 周宏學 無
- 陳威君 無
- Chyong-Huey Lai 無
- Yun-Hsin Tang 無
- Cheng-Tao Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee 無
- YEN-SHEN LU 無
- 黃柏翔 無
- 徐偉勛 無
- TSUNG-HAO LIU 無
- WEI-LI MA 無
- YU-YUN SHAO 無
- Wei-Wu Chen 無
- Chih-Hung Hsu 無
- 張端瑩 無
- Wen-Fang Cheng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
- Incidence of AE/SAE
- Incidence of DLT
- Changes in laboratory findings, ECG, and vital signs since the baseline period
- Changes in physical examination (including ECOG performance status)
Inclution 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 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:
Cohort B1 (Biliary Tract Cancer)
Cohort B2 (Ovarian Cancer)
Cohort B3 (Breast Cancer)
Cohort B4 (Endometrial Cancer)
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 or endometrial cancer.
Exclusion Criteria
Treatment with any of the following:
Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
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
Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
Cytotoxic treatment: 21 days
Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
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:
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.
Uncontrolled hypertension.
Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.
History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
Symptomatic heart failure (NYHA class ≥ 2).
Prior or current cardiomyopathy.
Severe valvular heart disease.
Mean resting QTcF > 470 msec.
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.
Additional Exclusion Criteria for Part A Sub study 2
Thromboembolic event within 3 months before the first dose of study intervention.
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.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
445 participants
