RECRUITING
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A Phase 1/2a Study of DB-1303/BNT323 in 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.
Conditions:
🦠 HER2-positive Advanced Solid Tumor
🗓️ Study Start (Actual) 31 January 2022
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) October 2025
👥 Enrollment (Estimated) 766
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Cerritos, California, United States
📍 Los Angeles, California, United States
📍 Washington, District of Columbia, United States
📍 Coral Springs, Florida, United States
📍 Lakeland, Florida, United States
📍 Margate, Florida, United States
📍 Miami, Florida, United States
📍 Plantation, Florida, United States
📍 Tamarac, Florida, United States
📍 Newnan, Georgia, United States
📍 Honolulu, Hawaii, United States
📍 Covington, Louisiana, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Dearborn, Michigan, United States
📍 Saint Louis, Missouri, United States
📍 Las Vegas, Nevada, United States
📍 Lake Success, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Shirley, New York, United States
📍 Wilson, North Carolina, United States
📍 Canton, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Nashville, Tennessee, United States
📍 Houston, Texas, United States
📍 Laredo, Texas, United States
📍 Fairfax, Virginia, United States
📍 Seattle, Washington, United States
📍 Randwick, New South Wales, Australia
📍 Sydney, New South Wales, Australia
📍 South Brisbane, Queensland, Australia
📍 Bengbu, Anhui, China
📍 Hefei, Anhui, China
📍 Hefei, Anhui, China
📍 Beijing, Beijing, China
📍 Beijing, Beijing, China
📍 Jilian, Changchun, China
📍 Xiamen, Fujian, China
📍 Guangzhou, Guangdong, China
📍 Guangzhou, Guangdong, China
📍 Guangzhou, Guangdong, China
📍 Nanning, Guangxi, China
📍 Yulin, Guangxi, China
📍 Baoding, Hebei, China
📍 Zhengzhou, Hehan, China
📍 Zhengzhou, Henan, China
📍 Wuhan, Hubei, China
📍 Changsha, Hunan, China
📍 Changsha, Hunan, China
📍 Changsha, Hunan, China
📍 Changzhou, Jiangsu, China
📍 Wuxi, Jiangsu, China
📍 Xuzhou, Jiangsu, China
📍 Xuzhou, Jiangsu, China
📍 Nanchang, Jiangxi, China
📍 Nanchang, Jiangxi, China
📍 Shenyang, Liaoning, China
📍 Xi'an, Shaanxi, China
📍 Jinan, Shandong, China
📍 Jinan, Shandong, China
📍 Jinan, Shandong, China
📍 Liaocheng, Shandong, China
📍 Zibo, Shandong, China
📍 Yantai, Shangdong, China
📍 Shanghai, Shanghai, China
📍 Shanghai, Shanghai, China
📍 Tianjin, Tianjin, China
📍 Kunming, Yunnan, China
📍 Hangzhou, Zhejiang, China
📍 Hangzhou, Zhejiang, China
📍 Hangzhou, Zhejiang, China
📍 Wenzhou, Zhejiang, China
📍 Mayaguez, Puerto Rico
More locations available...

📋 Eligibility Criteria

Description

    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.

    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.
    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 November 2021
  • First Submitted that Met QC Criteria 26 November 2021
  • First Posted 9 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 27 June 2024
  • Last Verified June 2024
I'm interested ...!!