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AzTrials

HER2-positive Advanced Solid TumorPhase 1/2NCT05150691

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

A Phase 1/2 study testing DB-1303/BNT323, Pertuzumab Injection and Ritonavir in people with HER2-positive Advanced Solid Tumor, run by DualityBio Inc. at 102 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Advanced Solid Tumor
What is being tested?
DB-1303/BNT323, Pertuzumab Injection and Ritonavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
796 participants
Where
102 sitesin 6 countries
Study dates
31 Jan 2022to Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

102 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Britney Winterberger contact

+1-513-403-8568

britney.winterberger@tigermedgrp.com

102 sites in 6 countries

China50 sites, 46 recruiting

  • Anyang Tumor Hospital

    Anyang, Henan

    Recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality

    Recruiting

  • The first affiliated hospital of Bengbu medical college

    Bengbu, Anhui

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Recruiting

  • Hunan People's Provincial Hospital

    Changsha, Hunan

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Recruiting

  • Changzhou Tumor Hospital

    Changzhou, Jiangsu

    Withdrawn

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Recruiting

  • The First affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Recruiting

  • Huizhou First Hospital

    Guangzhou, Guangdong

    Recruiting

  • Sun Yat-Sen Memorial Hospital of Zhongshan University

    Guangzhou, Guangdong

    Recruiting

  • The First affiliated hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Recruiting

  • 1st affliated hospital of Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

  • The second affiliated hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Recruiting

  • Women's hospital school of medicine Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Anhui provincial hospital

    Hefei, Anhui

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Recruiting

  • The First Hospital of Jilin University

    Hongcun, Changchun

    Recruiting

  • Central hospital affiliated to Shandong first medical university

    Jinan, Shandong

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong

    Recruiting

  • Shandong Cancer hospital & institute

    Jinan, Shandong

    Recruiting

  • Affiliated hospital of Jining medical university

    Jining, Shandong

    Recruiting

  • Yunnan Provincial Cancer Hospital

    Kunming, Yunnan

    Recruiting

  • Gansu Provincial Maternity and Child-care Hospital

    Lanzhou, Gansu

    Recruiting

  • Linyi Tumor Hospital

    Liaocheng, Shandong

    Recruiting

  • Jiangxi maternal and child health hospital

    Nanchang, Jiangxi

    Recruiting

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi

    Recruiting

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

    Recruiting

  • Fudan University

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai Tenth people's Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • The Obstetrics & Gynecology Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Recruiting

  • Liaoning cancer hospital & Institute

    Shenyang, Liaoning

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Recruiting

  • Tianjin Medical university cancer institute & hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Withdrawn

  • Union hospital Tongji Medical college Huazhong university of science and technology

    Wuhan, Hubei

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

    Recruiting

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Recruiting

  • The First affiliated hospital of Xiamen University

    Xiamen, Fujian

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

    Recruiting

  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu

    Withdrawn

  • Yantai Yuhuangding Hospital

    Yantai, Shangdong

    Withdrawn

  • The First people's hospital of Yulin

    Yulin, Guangxi

    Recruiting

  • Henan cancer Hospital

    Zhengzhou, Hehan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

  • Zibo Central hospital

    Zibo, Shandong

    Recruiting

Other trials in China

United States35 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

    Active, not recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Active, not recruiting

  • Helios Clinical Research

    Cerritos, California, 90703

    Active, not recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Active, not recruiting

  • Advanced Research LLC

    Coral Springs, Florida, 33065

    Active, not recruiting

  • Women's Cancer Care

    Covington, Louisiana, 70433

    Withdrawn

  • Profound Research LLC/Michigan Hematology & Oncology Consultants

    Dearborn, Michigan, 48126

    Withdrawn

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Active, not recruiting

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Active, not recruiting

  • Clinical Trial Network

    Houston, Texas, 77074

    Withdrawn

  • Northwell Health

    Lake Success, New York, 11042

    Withdrawn

  • The Oncology Institute of Hope and Innovation

    Lakeland, Florida, 33812

    Active, not recruiting

  • Oncology and Hematology of South Texas, PA

    Laredo, Texas, 78041

    Active, not recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Withdrawn

  • California Research Institute

    Los Angeles, California, 90027

    Active, not recruiting

  • D&H Cancer Research Center LLC

    Margate, Florida, 33063

    Active, not recruiting

  • HCA Mercy Hospital

    Miami, Florida, 33133

    Withdrawn

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYC Langone Health

    New York, New York, 10016

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Active, not recruiting

  • Southeastern Regional Medical Center, LLC

    Newnan, Georgia, 30265

    Active, not recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    Active, not recruiting

  • Rittenhouse Hematology Oncology

    Philadelphia, Pennsylvania, 19107

    Withdrawn

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Active, not recruiting

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Active, not recruiting

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

    Active, not recruiting

  • Sharp Memorial Hospital

    San Diego, California, 92123

    Active, not recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Active, not recruiting

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

    Shirley, New York, 11967

    Active, not recruiting

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

    Withdrawn

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141

    Active, not recruiting

  • BRCR Medical Center Inc.

    Tamarac, Florida, 33321

    Active, not recruiting

  • Washington Cancer Institute at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Active, not recruiting

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893

    Withdrawn

Other trials in United States

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, Changhua County, 50006

    Active, not recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Zuoying District, 81362

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, Beitou District, 11217

    Active, not recruiting

  • Taipei Medical University Hospital

    Taipei, Xinyi District, 110301

    Active, not recruiting

  • Taipei Medical University-Shuang Ho Hospital

    Taipei, Zhonghe District, 235041

    Active, not recruiting

  • Mackay Memorial Hospital-Taipei

    Taipei, Zhongshan District, 10449

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, Zhongzheng District, 100225

    Active, not recruiting

Other trials in Taiwan

South Korea5 sites

  • Seoul National University Bundang Hospital

    Gyeonggi-do, Bundang-gu, 13620

    Active, not recruiting

  • National Cancer Center

    Gyeonggi-do, Ilsandong-gu, 10408

    Active, not recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

    Active, not recruiting

  • Severance Hospital

    Seoul, Seodaemun-gu, 03722

    Active, not recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

    Active, not recruiting

Other trials in South Korea

Australia4 sites

  • Monash Health

    Melbourne, Victoria, 3168

    Active, not recruiting

  • Scientia Clinical Research LTD

    Randwick, New South Wales, 2031

    Active, not recruiting

  • Integrated Clinical Oncology Network Pty Ltd (Icon)

    South Brisbane, Queensland, 4101

    Active, not recruiting

  • Macquarie Clinical Trials Unit

    Sydney, New South Wales, 2109

    Active, not recruiting

Other trials in Australia

Puerto Rico1 site

  • BRCR Global Puerto Rico LLC.

    Mayagüez, 00682

    Withdrawn

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
DB-1303/BNT323, Pertuzumab Injection, Ritonavir, Itraconazole
Keywords
HER2, HER2-positive, HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Endometrial Cancer, HER2-positive Biliary Tract Cancer, HER2-positive Advanced Solid Tumor, HER2 low, HER2 high, metastatic cancer, HER2-positive GEJ, Uterine serous papillary carcinoma, USPC, recurrent cancer, carcinoma, neoplasms, breast neoplasms, gastrointestinal neoplasms, endometrial neoplasms, biliary tract neoplasms
Medical subject headings
Neoplasm Metastasis, Recurrence, Carcinoma, Neoplasms, Breast Neoplasms, Gastrointestinal Neoplasms, Endometrial Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DB-1303/BNT323Biological

    Administered IV

  • Pertuzumab InjectionDrug

    Administered IV

  • RitonavirDrug

    Administered oral

  • ItraconazoleDrug

    Administered oral

Study groups in NCT05150691
Study groupRoleWhat they receive
DB-1303/BNT323 Dose Level 1ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 2ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 3ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 4ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 5ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 1ExperimentalEnrolled 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
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 2ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 3ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 4ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 5ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 6ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 7ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 6ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 7ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 8ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 9ExperimentalEnrolled 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
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 10ExperimentalEnrolled 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
Receives: Biological: DB-1303/BNT323; Drug: Ritonavir; Drug: Itraconazole
DB-1303/BNT323 Dose Expansion 11ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 12ExperimentalEnrolled 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
Receives: Biological: DB-1303/BNT323; Drug: Pertuzumab Injection
DB-1303/BNT323 Dose Expansion 13ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 14ExperimentalChina 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
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 15ExperimentalChina Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 16ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 17ExperimentalEnrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Receives: Biological: DB-1303/BNT323

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.

    Percentage of participants in Part 1 with DLTs

    Measured: up to 21 days after C1D1

  2. 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).

    Measured: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  3. 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

    Measured: Up to follow-up period, approximately 1 year post-treatment

  4. Phase 1: Maximum Tolerated Dose (MTD) of DB-1303

    MTD on the data collected during Part 1

    Measured: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  5. Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303

    RP2D of DB-1303 based on the data collected during Part 1

    Measured: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  6. 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).

    Measured: Up to follow-up period, approximately 1 year post-treatment

  7. 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

    Measured: Up to follow-up period, approximately 1 year post-treatment

  8. 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.

    Measured: Up to follow-up period, approximately 1 year post-treatment

  9. 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)

    Measured: up to safety follow-up visit, approx. 35 days post-treatment

  10. 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)

    Measured: up to safety follow-up visit, approx. 35 days post-treatment

Secondary outcomes (16)

  1. Phase 1 & Phase 2: Pharmacokinetic-AUC

    Area under the concentration-time curve from time 0 to infinity of DB-1303

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  2. Phase 1 & Phase 2: Pharmacokinetic-Cmax

    Maximum observed plasma concentration (Cmax) of DB-1303

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  3. Phase 1 & Phase 2: Pharmacokinetic-Tmax

    Time to Cmax of DB-1303

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  4. Phase 1 & Phase 2: Pharmacokinetic-T1/2

    Terminal elimination half-life

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  5. Phase 1 & Phase 2: Pharmacokinetic-Ctrough

    Trough concentration of DB-1303

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  6. Phase 1 & Phase 2: Pharmacodynamics-ADA

    Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.

    Measured: Up to safety follow up visit, approx. 35 days post-treatment

  7. Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1

    Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.

    Measured: Up to follow-up period, approximately 1 year post-treatment

  8. Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1

    The duration of time from date of first CR or PR to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1

    Measured: Up to follow-up period, approximately 1 year post-treatment

  9. Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1

    The duration of time when receiving the first dose of study drug to the first date that is evaluated as either CR or PR using RECIST V1.1

    Measured: Up to follow-up period, approximately 1 year post-treatment

  10. Phase 2: Time on Therapy

    The duration of time from participant receiving first dose of study drug to the last dose + 21 days

    Measured: Up to 21 days after the participant's last dose

  11. Phase 2: Percent change in target lesions as assessed by RECIST 1.1

    The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1

    Measured: Up to follow-up period, approximately 1 year post-treatment

  12. Phase 1 and 2 Cohort b only: Progression-Free Survival

    Time from subject receiving the first dose to disease progression or death by any cause

    Measured: Up to follow-up period, approximately 1 year post-treatment

  13. Phase 1 and 2 Cohort b only: Overall Survival

    Time from subject receiving the first dose to death by any cause

    Measured: Up to follow-up period, approximately 1 year post-treatment

  14. Phase I: Percentage of Objective Response Rate (ORR) as assessed by investigator based on RECIST 1.1

    The percentage of subjects who had a best response of CR or PR

    Measured: Up to follow-up period, approximately 1 year post-treatment

  15. Phase 2 Cohort b Only: Percentage of ORR as assessed by IRC and as assessed by investigator based on RECIST 1.1 for HER2-expressing subjects and in subjects with prior ICI treatment

    The percentage of subjects who had a best response of CR or PR, for Cohort 2b only

    Measured: Up to follow-up period, approximately 1 year post-treatment

  16. To evaluate the safety of DB-1303 with/without ritonavir or itraconazole

    Percentage of Participants with Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAE), TEAEs >/= G3, or TEAEs leading to dose reduction, interruption or discontinuation, Adverse Events of Special Interest, (AESIs), abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).

    Measured: Up to follow-up period, approximately 1 year post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start31 Jan 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
796 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150691
Sponsor's protocol ID
DB-1303-O-1001
Status last verified
Aug 2026
First submitted
11 Nov 2021
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DB-1303/BNT323, Pertuzumab Injection and Ritonavir in people with HER2-positive Advanced Solid Tumor, run by DualityBio Inc. at 102 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in China, United States, Taiwan, South Korea, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Britney Winterberger (+1-513-403-8568, britney.winterberger@tigermedgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. (time frame: up to 21 days after C1D1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05150691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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