Breast CancerPhase 1/2NCT05123482
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
A Phase 1/2 study testing AZD8205, AZD8205 and AZD2936 (Rilvegostomig) and AZD8205 and AZD5305 (saruparib) in people with Breast Cancer and Biliary Tract Carcinoma, run by AstraZeneca at 67 sites in 15 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer
- What is being tested?
- AZD8205, AZD8205 and AZD2936 (Rilvegostomig) and AZD8205 and AZD5305 (saruparib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 67 sitesin 15 countries
- Study dates
- 18 Oct 2021to 29 Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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.
- 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
Trial locations and contacts
67 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
67 sites in 15 countries
United States14 sites, 10 recruiting
- Recruiting
Research Site
Albuquerque, New Mexico, 87109
- Recruiting
Research Site
Baltimore, Maryland, 21231
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Charlotte, North Carolina, 28204
- Recruiting
Research Site
Commack, New York, 11725
- Completed
Research Site
Duarte, California, 91010
- Recruiting
Research Site
Houston, Texas, 77030
- Completed
Research Site
Irvine, California, 92618
- Withdrawn
Research Site
New York, New York, 10029
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15213
- Recruiting
Research Site
Santa Monica, California, 90404
- Recruiting
Research Site
Santa Rosa, California, 95403
- Completed
Research Site
Shreveport, Louisiana, 71103
- Recruiting
Research Site
St Louis, Missouri, 63110
China8 sites, 5 recruiting
- Completed
Research Site
Beijing, 100142
- Recruiting
Research Site
Beijing, 100142
- Terminated
Research Site
Changsha, 410013
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chongqing, 400030
- Completed
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Kunming, 650118
- Recruiting
Research Site
Shandong
Japan6 sites, 6 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Kurume-shi, 830-0011
- Recruiting
Research Site
Sunto-gun, 411-8777
Canada5 sites, 4 recruiting
- Recruiting
Research Site
Calgary, Alberta, T2N 5G2
- Completed
Research Site
Montreal, Quebec, H4A 3J1
- Recruiting
Research Site
Ottawa, Ontario, K1H 8L6
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
- Recruiting
Research Site
Vancouver, British Columbia, V5Z 4E6
Spain5 sites, 5 recruiting
- Recruiting
Research Site
Barcelona, 8035
- Recruiting
Research Site
L'Hospitalet de Llobregat, 08908
- Recruiting
Research Site
Madrid, 28027
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Pamplona, 31008
Taiwan5 sites, 5 recruiting
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 11259
- Recruiting
Research Site
Taoyuan, 333
Italy4 sites, 4 recruiting
- Recruiting
Research Site
Milan, 20141
- Recruiting
Research Site
Milan, 20159
- Recruiting
Research Site
Modena, 41125
- Recruiting
Research Site
Roma, 00168
South Korea4 sites, 4 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 06351
Australia3 sites, 1 recruiting
- Terminated
Research Site
Clayton, 3168
- Recruiting
Research Site
Melbourne, VIC 3000
- Active, not recruiting
Research Site
Nedlands, 6009
Hungary3 sites, 2 recruiting
- Withdrawn
Research Site
Budapest, 1062
- Recruiting
Research Site
Budapest, 1082
- Recruiting
Research Site
Budapest, 1122
United Kingdom3 sites, 2 recruiting
- Recruiting
Research Site
Cambridge, CB2 0XY
- Completed
Research Site
Cardiff, CF14 2TL
- Recruiting
Research Site
London, EC1A 7BE
Belgium2 sites, 2 recruiting
- Recruiting
Research Site
Anderlecht, 1070
- Recruiting
Research Site
Leuven, 3000
Poland2 sites, 2 recruiting
- Recruiting
Research Site
Gdansk, 80-214
- Recruiting
Research Site
Warsaw, 02-781
Thailand2 sites
- Completed
Research Site
Bangkok, 10330
- Active, not recruiting
Research Site
Chiang Mai, 50200
Netherlands1 site, 1 recruiting
- Recruiting
Research Site
Amsterdam, 1066 CX
About this study
Official title: 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
Read the detailed description
This study is 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
- Conditions
- Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer, Endometrial Cancer, Squamous Non-Small Cell Lung Cancer
- Being tested
- AZD8205, AZD8205 and AZD2936 (Rilvegostomig), AZD8205 and AZD5305 (saruparib), AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig), AZD8205 in combination with AZD9574
- Keywords
- First In Human, antibody drug conjugate, cancer, solid tumour, Phase I, Phase IIa
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8205Drug
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 and AZD2936 (Rilvegostomig)Drug
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 and AZD5305 (saruparib)Drug
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 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)Drug
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 in combination with AZD9574Drug
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 in combination with AZD9574 plus rilvegostomig (AZD2936)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sub-Study 1 AZD8205 Monotherapy | Experimental | Sub-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. Receives: Drug: AZD8205 |
| Sub Study 2: AZD8205 in combination with rilvegostomig | Experimental | Sub-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. Receives: Drug: AZD8205 and AZD2936 (Rilvegostomig) |
| Sub-Study 3 AZD8205 in combination with saruparib, with or without rilvegostomig | Experimental | Sub-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. Receives: Drug: AZD8205 and AZD5305 (saruparib); Drug: AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig) |
| Sub-Study 4: AZD8205 in combination with AZD9574 with or without rilvegostomig (AZD2936) | Experimental | Sub-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. Receives: Drug: AZD8205 in combination with AZD9574; Drug: AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
Measured: 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
Measured: 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.
Measured: 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.
Measured: From time of informed consent to 30 days post last dose (approximately 1 year)
Secondary outcomes (21)
Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1).
Measured: From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Duration of response (DoR)
The time from the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression.
Measured: From the first documented response to confirmed progressive disease or death ( approx. 2 years )
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment.
Measured: 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)
Percentage of patients with confirmed CR or PR or having SD maintained for >= 11 weeks from first dose (RECIST 1.1).
Measured: Measured from first dose until progression. For each patient, this is expected to be at 12 weeks
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause.
Measured: From first dose of AZD8205 to death ( approx. 2 years )
Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max)
Time to maximum observed plasma concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Immunogenicity of AZD8205.
The number and percentage of participants who develop ADAs.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub Study 1: AZD8205 monotherapy Pharmacodynamics
To assess the intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered as a monotherapy.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub Study 2: AZD8205 in combination with rilvegostomig Pharmacodynamics
To assess the change in intratumoral pharmacodynamic biomarkers (gamma H2AX H-scores) to AZD8205 when administered in combination with rilvegostomig.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Sub-study 2: Rilvegostomig Pharmacokinetics when in combination with AZD8205
To characterize the PK serum concentrations and PK parameters of rilvegostomig in combination with AZD8205.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 2: Immunogenicity of Rilvegostomig when in combination with AZD8205
The number and percentage of participants who develop ADAs.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 3: Pharmacokinetics of saruparib in combination with AZD8205 with or without rilvegostomig
To characterize the PK plasma concentration and PK parameters of saruparib, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, of saruparib when given in combination with AZD8205 with or without rilvegostomig.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 3: Pharmacokinetics of rilvegostomig in combination with AZD8205 and saruparib
To characterize the PK serum concentrations and PK parameters (where applicable) of rilvegostomig when given in combination with AZD8205 and saruparib.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 3: Immunogenicity of rilvegostomig in combination with AZD8205 and saruparib
The number and percentage of participants who develop ADAs.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 4: Pharmacokinetics of AZD9574 in combination with AZD8205 with or without rilvegostomig
To characterize the PK plasma concentration and PK parameters of AZD9574, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, of AZD9574 when given in combination with AZD8205 with or without rilvegostomig.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-study 4: Pharmacokinetics of rilvegostomig in combination with AZD8205 and AZD9574
To characterize the PK serum concentrations and PK parameters (where applicable) of rilvegostomig when given in combination with AZD8205 and AZD9574.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Sub-Study 4: Immunogenicity of rilvegostomig in combination with AZD8205 and AZD9574
The number and percentage of participants who develop ADAs.
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 (approx 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start18 Oct 2021
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study consists a master protocol with sub studies each evaluating the safety and tolerability of AZD8205 dosed as monotherapy, or in Combination with Anticancer Agents in Participants with Advanced Solid Tumours: Sub Study 1 (AZD8205 monotherapy) * Part A Dose Escalation * Part B Dose Expansion Sub Study 2 (AZD8205 in combination with rilvegostomig) * Part A Dose Escalation * Part B Dose Expansion Sub Study 3 (AZD8205 in combination with saruparib with or without rilvegostomig) * Part A Dose Escalation * Part B Dose Expansion Sub Study 4 (AZD8205 in combination with AZD9574 with or without rilvegostomig) * Part A Dose Escalation * Part B Dose Expansion
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123482
- Sponsor's protocol ID
- D6900C00001
- Other IDs
- 2022-502759-70-01, 2021-000736-66
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39392424