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AZD8205

Phase 1

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment460

FDA Designations

No designations recorded

Clinical trial landscape

AZD8205 · 1 trial · 5 indications

Phase 1 1
NCT05123482A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid MalignanciesBreast Cancer
RECRUITING460 Analytics
PHASE1RECRUITING
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of patients with adverse events
From time of Informed consent to 30 days post last dose (approximately 1 year).

Number of patients with adverse events by system organ class and preferred term

The number of patients with serious adverse events
From time of Informed consent to 30 days post last dose (approximately 1 year)

Number of patients with serious adverse events by system organ class and preferred term

The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
From first dose of study treatment until the end of Cycle 1 (approximately 21 days).

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.

The number of patients with changes from baseline laboratory findings, ECGs and vital signs
From time of informed consent to 30 days post last dose (approximately 1 year)

Description of laboratory findings and vital signs variables over time including change from baseline.

Secondary Endpoints

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 )
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sub-Study 1 AZD8205 MonotherapyEXPERIMENTALSub-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 rilvegostomigEXPERIMENTALSub-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 rilvegostomigEXPERIMENTALSub-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

NameTypeDescription
AZD8205DRUGAZD8205 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 and AZD2936 (Rilvegostomig)DRUGAZD8205 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 and AZD5305 (saruparib)DRUGAZD8205 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 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)DRUGAZD8205 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 in combination with AZD9574DRUGAZD8205 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 in combination with AZD9574 plus rilvegostomig (AZD2936)DRUGAZD8205 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites67

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 toler...

Countries:United StatesAustraliaBelgiumCanadaChinaHungaryItalyJapanNetherlandsPolandSouth KoreaSpainTaiwanThailandUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT05123482lastUpdatePostDate: changed
LOWAug 12, 2026NCT05123482lastUpdatePostDate: changed
LOWJul 17, 2026NCT05123482lastUpdatePostDate: changed
LOWJul 17, 2026NCT05123482lastUpdatePostDate: changed
LOWJul 17, 2026NCT05123482lastUpdatePostDate: changed
LOWJun 18, 2026NCT05123482lastUpdatePostDate: changed
LOWJun 18, 2026NCT05123482lastUpdatePostDate: changed
LOWJun 18, 2026NCT05123482lastUpdatePostDate: changed
LOWJun 18, 2026NCT05123482lastUpdatePostDate: changed

Frequently asked questions about AZD8205

What is AZD8205 used for in breast cancer?

AZD8205 is an investigational small molecule being studied for the treatment of breast cancer. It is currently in Phase 1 clinical development, with a trial enrolling participants with advanced or metastatic solid malignancies, including breast cancer. The drug is being evaluated alone or in combination, and is not yet approved by regulatory authorities.

What does AZD8205 target?

AZD8205 is a small molecule being developed by AstraZeneca. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential in treating advanced or metastatic solid tumors, including breast cancer, but its mechanism of action is not publicly detailed.

Who makes AZD8205?

AZD8205 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials, and AstraZeneca is responsible for its research and development.

What phase is AZD8205 in?

AZD8205 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory body. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, tolerability, and preliminary efficacy in advanced or metastatic solid tumors.

What clinical trials is AZD8205 in?

AZD8205 is being studied in a single clinical trial registered as NCT05123482. This is a Phase I/IIa study of AZD8205 given alone or combined, in participants with advanced or metastatic solid malignancies. The trial is currently recruiting and has an estimated enrollment of 460 participants across multiple countries.

Is AZD8205 the same as any other drug?

AZD8205 is a distinct investigational compound developed by AstraZeneca. No alternative names or aliases for AZD8205 have been reported in the available clinical trial information. It is being studied under its unique identifier in a Phase 1 clinical trial for advanced solid tumors.