A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
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)
3 other identifiers
interventional
460
15 countries
67
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Oct 2021
Longer than P75 for phase_1 breast-cancer
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedStudy Start
First participant enrolled
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2027
March 23, 2026
March 1, 2026
6 years
October 13, 2021
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
From time of Informed consent to 30 days post last dose (approximately 1 year).
The number of patients with serious adverse events
Number of patients with serious adverse events by system organ class and preferred term
From time of Informed consent to 30 days post last dose (approximately 1 year)
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities.
From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
The number of patients with changes from baseline laboratory findings, ECGs and vital signs
Description of laboratory findings and vital signs variables over time including change from baseline.
From time of informed consent to 30 days post last dose (approximately 1 year)
Secondary Outcomes (21)
Objective Response Rate (ORR)
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Duration of response (DoR)
From the first documented response to confirmed progressive disease or death ( approx. 2 years )
Progression free Survival (PFS)
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Disease Control Rate at 12 weeks (DCR-12)
Measured from first dose until progression. For each patient, this is expected to be at 12 weeks
Overall Survival (OS)
From first dose of AZD8205 to death ( approx. 2 years )
- +16 more secondary outcomes
Study Arms (4)
Sub-Study 1 AZD8205 Monotherapy
EXPERIMENTALSub-Study 1 has two parts: Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose (RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205. Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.
Sub Study 2: AZD8205 in combination with rilvegostomig
EXPERIMENTALSub-Study 2 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + rilvegostomig Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + rilvegostomig in select solid tumors.
Sub-Study 3 AZD8205 in combination with saruparib, with or without rilvegostomig
EXPERIMENTALSub-Study 3 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + saruparib. Rilvegostomig may be added in a triplet combination once an AZD8205 + saruparib combination dose/schedule has been considered safe. Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + saruparib with or without rilvegostomig in select solid tumors.
Sub-Study 4: AZD8205 in combination with AZD9574 with or without rilvegostomig (AZD2936)
EXPERIMENTALSub-Study 4 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + AZD9574. Rilvegostomig may be added in a triplet combination once an AZD8205 + AZD9574 combination dose/schedule has been considered safe. Part B: may be added in the future depending on emerging data, following a formal protocol amendment.
Interventions
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers.
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
Eligibility Criteria
You may qualify if:
- 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
- Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer
- 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)
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (67)
Research Site
Duarte, California, 91010, United States
Research Site
Irvine, California, 92618, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Shreveport, Louisiana, 71103, United States
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Baltimore, Maryland, 21231, United States
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Boston, Massachusetts, 02215, United States
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St Louis, Missouri, 63110, United States
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Albuquerque, New Mexico, 87109, United States
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Commack, New York, 11725, United States
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New York, New York, 10029, United States
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Charlotte, North Carolina, 28204, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Houston, Texas, 77030, United States
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Clayton, 3168, Australia
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Melbourne, VIC 3000, Australia
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Nedlands, 6009, Australia
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Anderlecht, 1070, Belgium
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Leuven, 3000, Belgium
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Calgary, Alberta, T2N 5G2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100142, China
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Beijing, 100142, China
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Changsha, 410013, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Guangzhou, 510060, China
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Kunming, 650118, China
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Shandong, China
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Budapest, 1062, Hungary
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Milan, 20141, Italy
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Modena, 41125, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Kashiwa, 277-8577, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Sunto-gun, 411-8777, Japan
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Amsterdam, 1066 CX, Netherlands
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Gdansk, 80-214, Poland
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Warsaw, 02-781, Poland
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Barcelona, 8035, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28027, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11259, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
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Chiang Mai, 50200, Thailand
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Cambridge, CB2 0XY, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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London, EC1A 7BE, United Kingdom
Related Publications (1)
Huang Y, Tan HY, Yuan J, Mu R, Yang J, Ball K, Vijayakrishnan B, Masterson L, Kinneer K, Luheshi N, Liang M, Rosenbaum AI. Extensive Biotransformation Profiling of AZD8205, an Anti-B7-H4 Antibody-Drug Conjugate, Elucidates Pathways Underlying Its Stability In Vivo. Anal Chem. 2024 Oct 22;96(42):16525-16533. doi: 10.1021/acs.analchem.4c02309. Epub 2024 Oct 11.
PMID: 39392424DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
November 17, 2021
Study Start
October 18, 2021
Primary Completion (Estimated)
September 29, 2027
Study Completion (Estimated)
September 29, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared