A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
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
1 other identifier
interventional
796
6 countries
102
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Longer than P75 for phase_1
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedJanuary 28, 2026
January 1, 2026
4.2 years
November 11, 2021
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Percentage of participants in Part 1 with DLTs
up to 21 days after C1D1
Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
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.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
MTD on the data collected during Part 1
Up to Safety Follow-Up visit, approximately 35 days post-treatment
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303
RP2D of DB-1303 based on the data collected during Part 1
Up to Safety Follow-Up visit, approximately 35 days post-treatment
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.
Up to follow-up period, approximately 1 year post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)
up to safety follow-up visit, approx. 35 days post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)
up to safety follow-up visit, approx. 35 days post-treatment
Secondary Outcomes (16)
Phase 1 & Phase 2: Pharmacokinetic-AUC
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Cmax
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Tmax
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-T1/2
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Ctrough
Up to safety follow up visit, approx. 35 days post-treatment
- +11 more secondary outcomes
Study Arms (24)
DB-1303/BNT323 Dose Level 1
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 2
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 3
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 4
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 5
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 1
EXPERIMENTALEnrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 2
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 3
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 4
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 5
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 6
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Level 7
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 6
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 7
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 8
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 9
EXPERIMENTALEnrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 10
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential
DB-1303/BNT323 Dose Expansion 11
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 12
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 13
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 14
EXPERIMENTALChina Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 15
EXPERIMENTALChina Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 16
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323 Dose Expansion 17
EXPERIMENTALEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- 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.
- \. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DualityBio Inc.lead
- BioNTech SEcollaborator
Study Sites (102)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2021
First Posted
December 9, 2021
Study Start
January 31, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share