RecruitingPhase 1Phase 2NCT05797168

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors

Sponsor

AstraZeneca

Enrollment

506 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Endometrial Cancer Lung Adenocarcinoma

Summary

This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I/IIa study testing a new experimental drug called AZD5335, both alone and in combination with other treatments, in patients with solid tumors (cancers that form a mass). The study aims to establish safe doses and gather early evidence of how well it works. **You may be eligible if...** - You have a solid tumor (a cancer that forms a lump or mass) that has not responded to standard treatments - You are able to give informed consent and comply with the study requirements - You meet age, organ function, and performance criteria (your doctor will review specifics) **You may NOT be eligible if...** - You have certain serious health conditions or organ problems - You have had specific prior treatments that conflict with this study - You are pregnant or breastfeeding 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

DRUGAZD5335

IV Antibody-drug conjugate

DRUGSaruparib (AZD5305)

Oral PARP inhibitor

DRUGBevacizumab

IV Monoclonal antibody

DRUGCarboplatin

IV Alkylating agent

DRUGAZD9574

Oral PARP inhibitor

Locations(60)

Research Site

Duarte, California, United States

Research Site

Irvine, California, United States

Research Site

La Jolla, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Louisville, Kentucky, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

Columbus, Ohio, United States

Research Site

Portland, Oregon, United States

Research Site

Providence, Rhode Island, United States

Research Site

Providence, Rhode Island, United States

Research Site

Houston, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Liverpool, Australia

Research Site

Melbourne, Australia

Research Site

Edmonton, Alberta, Canada

Research Site

London, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Chengdu, China

Research Site

Chongqing, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Jinan, China

Research Site

Xi'an, China

Research Site

Zhengzhou, China

Research Site

Berlin, Germany

Research Site

Essen, Germany

Research Site

Freiburg im Breisgau, Germany

Research Site

Hanover, Germany

Research Site

Leipzig, Germany

Research Site

Mannheim, Germany

Research Site

Regensburg, Germany

Research Site

Haifa, Israel

Research Site

Ramat Gan, Israel

Research Site

Hidaka-shi, Japan

Research Site

Kashiwa, Japan

Research Site

Kōtoku, Japan

Research Site

Sunto-gun, Japan

Research Site

Tokyo, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Málaga, Spain

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Cambridge, United Kingdom

Research Site

Glasgow, Scotland, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05797168

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