RecruitingPhase 1Phase 2NCT05123482

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)


Sponsor

AstraZeneca

Enrollment

460 participants

Start Date

Oct 18, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I/IIa trial testing the safety and early effectiveness of a new antibody-drug conjugate (ADC) called AZD8205 — alone and in combination with other drugs — in people with advanced or metastatic solid cancers. ADCs are "smart bombs" that attach to a specific protein on cancer cells and deliver chemotherapy directly to them. This trial includes specific groups for breast cancer, ovarian cancer, biliary tract cancer, endometrial cancer, and lung cancer. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer that has been treated with standard therapy but progressed - Your cancer is measurable on scans - You are in good general health (ECOG 0–1) with adequate organ function - You fall into one of the cancer types studied: breast, ovarian, biliary tract, endometrial, or squamous non-small cell lung cancer - You have at least 12 weeks life expectancy **You may NOT be eligible if...** - You have had prior treatment with certain drugs in the same class as AZD8205 - You have significant eye problems or have had recent eye surgery - You have active brain metastases requiring treatment - You are pregnant or breastfeeding - You have severe cardiac, liver, or kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD8205

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.

DRUGAZD8205 and AZD2936 (Rilvegostomig)

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.

DRUGAZD8205 and AZD5305 (saruparib)

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.

DRUGAZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)

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.

DRUGAZD8205 in combination with AZD9574

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.

DRUGAZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936)

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.


Locations(67)

Research Site

Duarte, California, United States

Research Site

Irvine, California, United States

Research Site

Santa Monica, California, United States

Research Site

Santa Rosa, California, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Commack, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Clayton, Australia

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Melbourne, Australia

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Nedlands, Australia

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Anderlecht, Belgium

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Leuven, Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Beijing, China

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Changsha, China

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Changsha, China

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Chongqing, China

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Guangzhou, China

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Kunming, China

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Shandong, China

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Milan, Italy

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Modena, Italy

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Roma, Italy

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Rozzano, Italy

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Chūōku, Japan

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Hidaka-shi, Japan

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Kashiwa, Japan

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Kōtoku, Japan

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Kurume-shi, Japan

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Sunto-gun, Japan

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Amsterdam, Netherlands

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Gdansk, Poland

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Warsaw, Poland

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

Research Site

L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Málaga, Spain

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Pamplona, Spain

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

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Bangkok, Thailand

Research Site

Chiang Mai, Thailand

Research Site

Cambridge, United Kingdom

Research Site

Cardiff, United Kingdom

Research Site

London, United Kingdom

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NCT05123482


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