Recruiting
Phase 1
Phase 2

DB-1303/BNT323

Sponsor:

DualityBio Inc.

Code:

NCT05150691

Conditions

HER2-positive Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DB-1303/BNT323

Pertuzumab Injection

Ritonavir

Itraconazole

Study Details

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.

Conditions

HER2-positive Advanced Solid Tumor

Study ID

NCT05150691

Start date

Jan 31, 2022

Status verified date

Apr, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

796 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DB-1303/BNT323 Dose Level 1

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 2

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 3

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 4

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 5

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 1

Enrolled 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

experimental: DB-1303/BNT323 Dose Expansion 2

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 3

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 4

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 5

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 6

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Level 7

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 6

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 7

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 8

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 9

Enrolled 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

experimental: DB-1303/BNT323 Dose Expansion 10

Enrolled 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

experimental: DB-1303/BNT323 Dose Expansion 11

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 12

Enrolled 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

experimental: DB-1303/BNT323 Dose Expansion 13

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 14

China 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

experimental: DB-1303/BNT323 Dose Expansion 15

China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 16

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

experimental: DB-1303/BNT323 Dose Expansion 17

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Interventions

DB-1303/BNT323

Administered IV

Pertuzumab Injection

Administered IV

Ritonavir

Administered oral

Itraconazole

Administered oral

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 ]
  • Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0 [ Time Frame: 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. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 1: Maximum Tolerated Dose (MTD) of DB-1303 [ Time Frame: Up to Safety Follow-Up visit, approximately 35 days post-treatment ]
  • Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: up to safety follow-up visit, approx. 35 days post-treatment ]

Central Contacts and Locations

Central contacts

Britney Winterberger

+1-513-403-8568britney.winterberger@tigermedgrp.com

Locations

TOI Clinical Research

Recruiting

Cerritos, California, United States, 90703

California Research Institute

Recruiting

Los Angeles, California, United States, 90027

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Washington Cancer Institute at MedStar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Advanced Research LLC

Recruiting

Coral Springs, Florida, United States, 33065

The Oncology Institute of Hope and Innovation

Recruiting

Lakeland, Florida, United States, 33812

D&H Cancer Research Center LLC

Recruiting

Margate, Florida, United States, 33063

HCA Mercy Hospital

Recruiting

Miami, Florida, United States, 33133

BRCR Medical Center Inc.

Recruiting

Plantation, Florida, United States, 33322

BRCR Medical Center Inc.

Recruiting

Tamarac, Florida, United States, 33321

Southeastern Regional Medical Center, LLC

Recruiting

Newnan, Georgia, United States, 30265

Kapi'olani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Holy Cross Hospital

Recruiting

Silver Spring, Maryland, United States, 20910

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02214

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

David C. Pratt Cancer Center

Recruiting

Saint Louis, Missouri, United States, 63141

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

Laura & Isaac Perlmutter Cancer Center at NYC Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

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

Recruiting

Shirley, New York, United States, 11967

Regional Medical Oncology Center

Recruiting

Wilson, North Carolina, United States, 27893

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

AHN West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Clinical Trial Network

Recruiting

Houston, Texas, United States, 77074

Oncology and Hematology of South Texas, PA

Recruiting

Laredo, Texas, United States, 78041

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

DualityBio Inc.

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

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
  • Antineoplastic Agents, Biological
  • stomach cancer
  • bile duct cancer
  • Cholangiocarcinoma
  • liver cancer
  • liver neoplasms
  • NSCLC
  • Non-Small Cell Lung Cancer
  • NSCLC HER2 mutation
  • HER2 Low Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by DualityBio Inc. on 2025-04-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.