RecruitingRecruiting
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
NCT05150691 · DualityBio Inc.
In plain English
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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/BNT323 in Patients With Advanced/Metastatic Solid Tumors
About this study
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
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.
Study design
Enrollment target: 796 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-01-31
Estimated completion: 2027-10
Last updated: 2026-01-28
Interventions
Biological: DB-1303/BNT323Drug: Pertuzumab InjectionDrug: RitonavirDrug: Itraconazole
Primary outcomes
- • Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. (up to 21 days after C1D1)
- • Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0 (Up to Safety Follow-Up visit, approximately 35 days post-treatment)
- • Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. (Up to follow-up period, approximately 1 year post-treatment)
Sponsor
DualityBio Inc. · industry
With: BioNTech SE
Contacts & investigators
ContactBritney Winterberger · contact · britney.winterberger@tigermedgrp.com · +1-513-403-8568
All locations (102)
Helios Clinical ResearchActive Not Recruiting
Cerritos, California, United States
California Research InstituteActive Not Recruiting
Los Angeles, California, United States
Sharp Memorial HospitalActive Not Recruiting
San Diego, California, United States
Washington Cancer Institute at MedStar Washington Hospital CenterActive Not Recruiting
Washington D.C., District of Columbia, United States
Advanced Research LLCActive Not Recruiting
Coral Springs, Florida, United States
The Oncology Institute of Hope and InnovationActive Not Recruiting
Lakeland, Florida, United States
D&H Cancer Research Center LLCActive Not Recruiting
Margate, Florida, United States
HCA Mercy HospitalWithdrawn
Miami, Florida, United States
BRCR Medical Center Inc.Active Not Recruiting
Plantation, Florida, United States
BRCR Medical Center Inc.Active Not Recruiting
Tamarac, Florida, United States
Southeastern Regional Medical Center, LLCActive Not Recruiting
Newnan, Georgia, United States
Kapi'olani Medical Center for Women and ChildrenActive Not Recruiting
Honolulu, Hawaii, United States
University of ChicagoActive Not Recruiting
Chicago, Illinois, United States
Women's Cancer CareWithdrawn
Covington, Louisiana, United States
Holy Cross HospitalWithdrawn
Silver Spring, Maryland, United States
Massachusetts General HospitalActive Not Recruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterActive Not Recruiting
Boston, Massachusetts, United States
Profound Research LLC/Michigan Hematology & Oncology ConsultantsWithdrawn
Dearborn, Michigan, United States
David C. Pratt Cancer CenterActive Not Recruiting
St Louis, Missouri, United States
Women's Cancer Center of NevadaWithdrawn
Las Vegas, Nevada, United States
Northwell HealthWithdrawn
Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone HealthActive Not Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterActive Not Recruiting
New York, New York, United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood SpecialistsActive Not Recruiting
Shirley, New York, United States
Regional Medical Oncology CenterWithdrawn
Wilson, North Carolina, United States
Gabrail Cancer CenterActive Not Recruiting
Canton, Ohio, United States
University of OklahomaActive Not Recruiting
Oklahoma City, Oklahoma, United States
Rittenhouse Hematology OncologyWithdrawn
Philadelphia, Pennsylvania, United States
Thomas Jefferson UniversityActive Not Recruiting
Philadelphia, Pennsylvania, United States
AHN West Penn HospitalActive Not Recruiting
Pittsburgh, Pennsylvania, United States
Tennessee OncologyActive Not Recruiting
Nashville, Tennessee, United States
Clinical Trial NetworkWithdrawn
Houston, Texas, United States
Oncology and Hematology of South Texas, PAActive Not Recruiting
Laredo, Texas, United States
NEXT VirginiaActive Not Recruiting
Fairfax, Virginia, United States
Swedish Cancer InstituteActive Not Recruiting
Seattle, Washington, United States
Scientia Clinical Research LTDActive Not Recruiting
Randwick, New South Wales, Australia
Macquarie Clinical Trials UnitActive Not Recruiting
Sydney, New South Wales, Australia
Integrated Clinical Oncology Network Pty Ltd (Icon)Active Not Recruiting
South Brisbane, Queensland, Australia
Monash HealthActive Not Recruiting
Melbourne, Victoria, Australia
The first affiliated hospital of Bengbu medical collegeRecruiting
Bengbu, Anhui, China
Anhui provincial hospitalRecruiting
Hefei, Anhui, China
The Second Hospital of Anhui Medical UniversityRecruiting
Hefei, Anhui, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical ScienceRecruiting
Beijing, Beijing Municipality, China
The First Hospital of Jilin UniversityRecruiting
Hongcun, Changchun, China
Chongqing University Cancer HospitalRecruiting
Chongqing, Chongqing Municipality, China
The First affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
The First affiliated hospital of Xiamen UniversityRecruiting
Xiamen, Fujian, China
Gansu Provincial Maternity and Child-care HospitalRecruiting
Lanzhou, Gansu, China
Huizhou First HospitalRecruiting
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Zhongshan UniversityRecruiting
Guangzhou, Guangdong, China
The First affiliated hospital, Sun Yat-sen UniversityRecruiting
Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical UniversityRecruiting
Nanning, Guangxi, China
The First people's hospital of YulinRecruiting
Yulin, Guangxi, China
Affiliated Hospital of Hebei UniversityRecruiting
Baoding, Hebei, China
Henan cancer HospitalRecruiting
Zhengzhou, Hehan, China
Anyang Tumor HospitalRecruiting
Anyang, Henan, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, Henan, China
Union hospital Tongji Medical college Huazhong university of science and technologyRecruiting
Wuhan, Hubei, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
Hunan People's Provincial HospitalRecruiting
Changsha, Hunan, China
Xiangya Hospital Central South UniversityRecruiting
Changsha, Hunan, China
Changzhou Tumor HospitalWithdrawn
Changzhou, Jiangsu, China
Affiliated Hospital of Jiangnan UniversityRecruiting
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical CollegeRecruiting
Xuzhou, Jiangsu, China
Xuzhou Cancer HospitalWithdrawn
Xuzhou, Jiangsu, China
Jiangxi maternal and child health hospitalRecruiting
Nanchang, Jiangxi, China
The Third Hospital of NanchangRecruiting
Nanchang, Jiangxi, China
Jilin Cancer HospitalRecruiting
Changchun, Jilin, China
Liaoning cancer hospital & InstituteRecruiting
Shenyang, Liaoning, China
The First Hospital of China Medical UniversityRecruiting
Shenyang, Liaoning, China
The First Affiliated Hospital Of Xi'an Jiaotong UniversityRecruiting
Xi'an, Shaanxi, China
Central hospital affiliated to Shandong first medical universityRecruiting
Jinan, Shandong, China
Jinan Central HospitalRecruiting
Jinan, Shandong, China
Shandong Cancer hospital & instituteRecruiting
Jinan, Shandong, China
Affiliated hospital of Jining medical universityRecruiting
Jining, Shandong, China
Linyi Tumor HospitalRecruiting
Liaocheng, Shandong, China
Zibo Central hospitalRecruiting
Zibo, Shandong, China
Yantai Yuhuangding HospitalWithdrawn
Yantai, Shangdong, China
Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China
Shanghai Tenth people's HospitalRecruiting
Shanghai, Shanghai Municipality, China
The Obstetrics & Gynecology Hospital Affiliated to Fudan UniversityRecruiting
Shanghai, Shanghai Municipality, China
Tianjin Medical university cancer institute & hospitalRecruiting
Tianjin, Tianjin Municipality, China
Yunnan Provincial Cancer HospitalRecruiting
Kunming, Yunnan, China
1st affliated hospital of Zhejiang UniversityRecruiting
Hangzhou, Zhejiang, China
The second affiliated hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
Women's hospital school of medicine Zhejiang UniversityRecruiting
Hangzhou, Zhejiang, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityWithdrawn
Wenzhou, Zhejiang, China
BRCR Global Puerto Rico LLC.Withdrawn
Mayagüez, Puerto Rico
Seoul National University Bundang HospitalActive Not Recruiting
Gyeonggi-do, Bundang-gu, South Korea
Samsung Medical CenterActive Not Recruiting
Seoul, Gangnam-gu, South Korea
National Cancer CenterActive Not Recruiting
Gyeonggi-do, Ilsandong-gu, South Korea
Severance HospitalActive Not Recruiting
Seoul, Seodaemun-gu, South Korea
Asan Medical CenterActive Not Recruiting
Seoul, Songpa-gu, South Korea
Taipei Veterans General HospitalActive Not Recruiting
Taipei, Beitou District, Taiwan
Changhua Christian HospitalActive Not Recruiting
Changhua, Changhua County, Taiwan
Taipei Medical University HospitalActive Not Recruiting
Taipei, Xinyi District, Taiwan
Taipei Medical University-Shuang Ho HospitalActive Not Recruiting
Taipei, Zhonghe District, Taiwan
Mackay Memorial Hospital-TaipeiActive Not Recruiting
Taipei, Zhongshan District, Taiwan
National Taiwan University HospitalActive Not Recruiting
Taipei, Zhongzheng District, Taiwan
Kaohsiung Veterans General HospitalActive Not Recruiting
Kaohsiung City, Zuoying District, Taiwan