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NCT05150691PHASE1, PHASE2Recruiting

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

DualityBio Inc.

Start Date

1/31/2022

Completion Date

10/1/2027

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Detailed Description

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), 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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. * At least 1 measurable lesion (per RECIST 1.1) * Provide signed informed consent * ECOG performance status (PS) of 0-1. * LVEF ≥ 50% by ECHO or MUGA * Adequate organ functions * Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing. * Life expectancy of ≥ 3 months. Additional Inclusion Criteria for Part 2 Expansion Group 9: 1\. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line. Exclusion Criteria: * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months before Day 1. * Average QTcF \> 450 ms in males and \> 470 ms in females * History of clinically significant lung diseases * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. * HIV infection with AIDS defining illness or active viral hepatitis. * Clinically active brain metastases * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline. * A known hypersensitivity to either the drug substances or inactive ingredients in the drug product. * Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Interventions

BIOLOGICAL

DB-1303/BNT323

DRUG

Pertuzumab Injection

DRUG

Ritonavir

DRUG

Itraconazole

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Conditions

HER2-positive Advanced Solid Tumor

Locations

Helios Clinical Research

Cerritos, California 90703

United States

California Research Institute

Los Angeles, California 90027

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Advanced Research LLC

Coral Springs, Florida 33065

United States

The Oncology Institute of Hope and Innovation

Lakeland, Florida 33812

United States

D&H Cancer Research Center LLC

Margate, Florida 33063

United States

HCA Mercy Hospital

Miami, Florida 33133

United States

BRCR Medical Center Inc.

Plantation, Florida 33322

United States

BRCR Medical Center Inc.

Tamarac, Florida 33321

United States

Southeastern Regional Medical Center, LLC

Newnan, Georgia 30265

United States

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii 96826

United States

University of Chicago

Chicago, Illinois 60637

United States

Women's Cancer Care

Covington, Louisiana 70433

United States

Holy Cross Hospital

Silver Spring, Maryland 20910

United States

Massachusetts General Hospital

Boston, Massachusetts 02214

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Profound Research LLC/Michigan Hematology & Oncology Consultants

Dearborn, Michigan 48126

United States

David C. Pratt Cancer Center

St Louis, Missouri 63141

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada 89106

United States

Northwell Health

Lake Success, New York 11042

United States

Laura & Isaac Perlmutter Cancer Center at NYC Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Regional Medical Oncology Center

Wilson, North Carolina 27893

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Rittenhouse Hematology Oncology

Philadelphia, Pennsylvania 19107

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

AHN West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Clinical Trial Network

Houston, Texas 77074

United States

Oncology and Hematology of South Texas, PA

Laredo, Texas 78041

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Scientia Clinical Research LTD

Randwick, New South Wales 2031

Australia

Macquarie Clinical Trials Unit

Sydney, New South Wales 2109

Australia

Integrated Clinical Oncology Network Pty Ltd (Icon)

South Brisbane, Queensland 4101

Australia

Monash Health

Melbourne, Victoria 3168

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 Municipality

China

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality

China

The First Hospital of Jilin University

Hongcun, Changchun

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality

China

The First affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality

China

The First affiliated hospital of Xiamen University

Xiamen, Fujian

China

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, Gansu

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

Anyang Tumor Hospital

Anyang, Henan

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 Cancer Hospital

Changsha, Hunan

China

Hunan People's Provincial Hospital

Changsha, Hunan

China

Xiangya Hospital Central South University

Changsha, Hunan

China

Changzhou Tumor Hospital

Changzhou, Jiangsu

China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu

China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, 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

Jilin Cancer Hospital

Changchun, Jilin

China

Liaoning cancer hospital & Institute

Shenyang, Liaoning

China

The First Hospital of China Medical University

Shenyang, Liaoning

China

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shaanxi

China

Central hospital affiliated to Shandong first medical university

Jinan, Shandong

China

Jinan Central Hospital

Jinan, Shandong

China

Shandong Cancer hospital & institute

Jinan, Shandong

China

Affiliated hospital of Jining medical university

Jining, Shandong

China

Linyi Tumor Hospital

Liaocheng, Shandong

China

Zibo Central hospital

Zibo, Shandong

China

Yantai Yuhuangding Hospital

Yantai, Shangdong

China

Fudan University

Shanghai, Shanghai Municipality

China

Shanghai Tenth people's Hospital

Shanghai, Shanghai Municipality

China

The Obstetrics & Gynecology Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality

China

Tianjin Medical university cancer institute & hospital

Tianjin, Tianjin Municipality

China

Yunnan Provincial Cancer Hospital

Kunming, Yunnan

China

1st affliated hospital of Zhejiang University

Hangzhou, Zhejiang

China

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang

China

Women's hospital school of medicine Zhejiang University

Hangzhou, Zhejiang

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang

China

BRCR Global Puerto Rico LLC.

Mayagüez, 00682

Puerto Rico

Seoul National University Bundang Hospital

Gyeonggi-do, Bundang-gu 13620

South Korea

Samsung Medical Center

Seoul, Gangnam-gu 06351

South Korea

National Cancer Center

Gyeonggi-do, Ilsandong-gu 10408

South Korea

Severance Hospital

Seoul, Seodaemun-gu 03722

South Korea

Asan Medical Center

Seoul, Songpa-gu 05505

South Korea

Taipei Veterans General Hospital

Taipei, Beitou District 11217

Taiwan

Changhua Christian Hospital

Changhua, Changhua County 50006

Taiwan

Taipei Medical University Hospital

Taipei, Xinyi District 110301

Taiwan

Taipei Medical University-Shuang Ho Hospital

Taipei, Zhonghe District 235041

Taiwan

Mackay Memorial Hospital-Taipei

Taipei, Zhongshan District 10449

Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng District 100225

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Zuoying District 81362

Taiwan