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New antibody drug combo targets Hard-to-Treat cancers

NCT ID NCT05123482

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests a new drug called AZD8205, alone or with another drug (rilvegostomig), in people with advanced solid tumors like breast, ovarian, and lung cancers. The trial has two phases: first to find the safest dose, then to see if it shrinks tumors. About 460 adults whose cancer has spread or returned after standard treatment will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD8205 (an antibody drug conjugate) and AZD2936 (Rilvegostomig, a bispecific antibody)
What this could lead to
If it works, this could provide a new treatment option for several advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) focused on safety and dosing, so it is not yet known if AZD8205 will be effective. Side effects are possible, and the drug may not work for all tumor types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 460 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 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: 1. Cohort B1 (Biliary Tract Cancer) 2. Cohort B2 (Ovarian Cancer) 3. Cohort B3 (Breast Cancer) 4. Cohort B4 (Endometrial Cancer) 5. 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. Key Exclusion Criteria: * Treatment with any of the following: 1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment 2. 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 3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention: 1. Cytotoxic treatment: 21 days 2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter) 3. 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: 1. 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. 2. Uncontrolled hypertension. 3. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months. 4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening. 5. Symptomatic heart failure (NYHA class ≥ 2). 6. Prior or current cardiomyopathy. 7. Severe valvular heart disease. 8. Mean resting QTcF \> 470 msec. 9. 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

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Conditions

The condition(s) this trial relates to.

bile duct carcinoma biliary tract cancer breast cancer breast neoplasm endometrial cancer endometrium neoplasm neoplasm non-small cell squamous lung carcinoma ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract carcinoma Breast cancer Endometrial cancer Ovarian cancer Squamous non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    55 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    COMPLETED

    Duarte, California, 91010, United States

  • Research Site

    COMPLETED

    Irvine, California, 92618, United States

  • Research Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • Research Site

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Research Site

    COMPLETED

    Shreveport, Louisiana, 71103, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Research Site

    RECRUITING

    Commack, New York, 11725, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10029, United States

  • Research Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    TERMINATED

    Clayton, 3168, Australia

  • Research Site

    RECRUITING

    Melbourne, VIC 3000, Australia

  • Research Site

    ACTIVE_NOT_RECRUITING

    Nedlands, 6009, Australia

  • Research Site

    RECRUITING

    Anderlecht, 1070, Belgium

  • Research Site

    RECRUITING

    Leuven, 3000, Belgium

  • Research Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Research Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    COMPLETED

    Beijing, 100142, China

  • Research Site

    RECRUITING

    Beijing, 100142, China

  • Research Site

    TERMINATED

    Changsha, 410013, China

  • Research Site

    RECRUITING

    Changsha, 410013, China

  • Research Site

    RECRUITING

    Chongqing, 400030, China

  • Research Site

    COMPLETED

    Guangzhou, 510060, China

  • Research Site

    RECRUITING

    Kunming, 650118, China

  • Research Site

    RECRUITING

    Shandong, China

  • Research Site

    WITHDRAWN

    Budapest, 1062, Hungary

  • Research Site

    RECRUITING

    Budapest, 1082, Hungary

  • Research Site

    RECRUITING

    Budapest, 1122, Hungary

  • Research Site

    RECRUITING

    Milan, 20141, Italy

  • Research Site

    RECRUITING

    Milan, 20159, Italy

  • Research Site

    RECRUITING

    Modena, 41125, Italy

  • Research Site

    RECRUITING

    Roma, 00168, Italy

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Hidaka-shi, 350-1298, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Kurume-shi, 830-0011, Japan

  • Research Site

    RECRUITING

    Sunto-gun, 411-8777, Japan

  • Research Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Research Site

    RECRUITING

    Gdansk, 80-214, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-781, Poland

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    RECRUITING

    Madrid, 28027, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Pamplona, 31008, Spain

  • Research Site

    RECRUITING

    Taichung, 40705, Taiwan

  • Research Site

    RECRUITING

    Tainan, 704, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11259, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    RECRUITING

    Bangkok, 10330, Thailand

  • Research Site

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Research Site

    RECRUITING

    Cambridge, CB2 0XY, United Kingdom

  • Research Site

    COMPLETED

    Cardiff, CF14 2TL, United Kingdom

  • Research Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

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