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A Study of AZD8205 for Advanced Solid Tumors

This study is testing a new drug called AZD8205, which is an antibody drug conjugate, for people with advanced or metastatic (spread to other parts of the body) solid tumors. It's being studied alone and in combination with other anti-cancer drugs like AZD2936 (rilvegostomig), AZD5305 (saruparib), and AZD9574. The study aims to see how safe these treatments are and what side effects they might cause. You may be able to join if you are 18 or older, have certain types of advanced solid tumors like breast cancer, ovarian cancer, or lung cancer, and have already received standard treatments or if a clinical trial is considered the best option. The study is looking for 460 participants, but its current recruitment status is unclear.

Study design
This is a Phase I/IIa, multi-center, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to test different doses and combinations of AZD8205.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events (side effects) and serious adverse events from the time you give consent until 30 days after your last dose, which is expected to be about one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05123482

A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~460 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:AZD8205AZD8205 and AZD2936 (Rilvegostomig)AZD8205 and AZD5305 (saruparib)AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)AZD8205 in combination with AZD9574AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936)

At a glance

Recruiting sites
55 of 67 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients with adverse events
Measured over From time of Informed consent to 30 days post last dose (approximately 1 year).
+3 more outcomes measured

Conditions

Breast Cancer
Biliary Tract Carcinoma
Ovarian Cancer
Endometrial Cancer
Squamous Non-Small Cell Lung Cancer

Explore related trials

Biliary Tract CarcinomaBreast CarcinomaEndometrial CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmSolid Neoplasm

Where it's being run

67 sites across 27 states
China8
Japan6
Spain5
Taiwan5
California4
Italy4
South Korea4
Australia3

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 and recurrent disease for the respective cohort:
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.
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.
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.

Exclusion

Treatment with any of the following:
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:
Patients with history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation)
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
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.)
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

What this trial measures

  • The number of patients with adverse eventsFrom 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 eventsFrom 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 signsFrom 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.