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Spots Global Cancer Trial Database for A Study of DB-1303 in Advanced/Metastatic Solid Tumors

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Trial Identification

Brief Title: A Study of DB-1303 in Advanced/Metastatic Solid Tumors

Official Title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients With Advanced/Metastatic Solid Tumors

Study ID: NCT05150691

Study Description

Brief Summary: This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.

Detailed Description: This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

TOI Clinical Research, Cerritos, California, United States

Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States

D&H Cancer Research Center LLC, Margate, Florida, United States

BRCR Medical Center Inc., Plantation, Florida, United States

BRCR Medical Center Inc., Tamarac, Florida, United States

Southeastern Regional Medical Center, LLC, Newnan, Georgia, United States

Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States

Women's Cancer Care, Covington, Louisiana, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

David C. Pratt Cancer Center, Saint Louis, Missouri, United States

Northwell Health, Lake Success, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYC Langone Health, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Gabrail Cancer Center, Canton, Ohio, United States

University of Oklahoma, Oklahoma City, Oklahoma, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Tennessee Oncology, Nashville, Tennessee, United States

Swedish Cancer Institute, Seattle, Washington, United States

Macquarie Clinical Trials Unit, Sydney, New South Wales, Australia

Integrated Clinical Oncology Network Pty Ltd (Icon), South Brisbane, Queensland, Australia

The first affiliated hospital of Bengbu medical college, Bengbu, Anhui, China

Anhui provincial hospital, Hefei, Anhui, China

The Second Hospital of Anhui Medical University, Hefei, Anhui, China

Beijing Cancer Hospital, Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China

The First Hospital of Jilin University, Jilian, Changchun, China

Huizhou First Hospital, Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Zhongshan University, Guangzhou, Guangdong, China

The First affiliated hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China

The First people's hospital of Yulin, Yulin, Guangxi, China

Affiliated Hospital of Hebei University, Baoding, Hebei, China

Henan cancer Hospital, Zhengzhou, Hehan, China

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

Union hospital Tongji Medical college Huazhong university of science and technology, Wuhan, Hubei, China

Hunan People's Provincial Hospital, Changsha, Hunan, China

Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China

Xuzhou Cancer Hospital, Xuzhou, Jiangsu, China

Jiangxi maternal and child health hospital, Nanchang, Jiangxi, China

The Third Hospital of Nanchang, Nanchang, Jiangxi, China

The First Hospital of China Medical University, Shenyang, Liaoning, China

Central hospital affiliated to Shandong first medical university, Jinan, Shandong, China

Shandong Cancer hospital & institute, Jinan, Shandong, China

Linyi Tumor Hospital, Liaocheng, Shandong, China

Zibo Central hospital, Zibo, Shandong, China

Yantai Yuhuangding Hospital, Yantai, Shangdong, China

Fudan University, Shanghai, Shanghai, China

Tianjin Medical university cancer institute & hospital, Tianjin, Tianjin, China

1st affliated hospital of Zhejiang University, Hangzhou, Zhejiang, China

The second affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

BRCR Global Puerto Rico LLC., Mayaguez, , Puerto Rico

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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