A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Recruiting · NCT05150691 · Interventional (participants receive a specific treatment) · Lead sponsor: DualityBio Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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:
- \. 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.
Where it is running
60 locations listed across 21 US states.
- Helios Clinical Research - Cerritos, California, United States
- Helios Clinical Research - Cerritos, California, United States
- California Research Institute - Los Angeles, California, United States
- California Research Institute - Los Angeles, California, United States
- Sharp Memorial Hospital - San Diego, California, United States
- Sharp Memorial Hospital - San Diego, California, United States
- Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Advanced Research LLC - Coral Springs, Florida, United States
- Advanced Research LLC - Coral Springs, Florida, United States
- The Oncology Institute of Hope and Innovation - Lakeland, Florida, United States
- The Oncology Institute of Hope and Innovation - Lakeland, Florida, United States
- D&H Cancer Research Center LLC - Margate, Florida, United States
- D&H Cancer Research Center LLC - Margate, Florida, United States
- HCA Mercy Hospital - Miami, Florida, United States
- HCA Mercy Hospital - Miami, Florida, United States
- BRCR Medical Center Inc. - Plantation, Florida, United States
- BRCR Medical Center Inc. - Plantation, Florida, United States
- BRCR Medical Center Inc. - Tamarac, Florida, United States
- BRCR Medical Center Inc. - Tamarac, Florida, United States
- Southeastern Regional Medical Center, LLC - Newnan, Georgia, United States
- Southeastern Regional Medical Center, LLC - Newnan, Georgia, United States
- Kapi'olani Medical Center for Women and Children - Honolulu, Hawaii, United States
- Kapi'olani Medical Center for Women and Children - Honolulu, Hawaii, United States
- University of Chicago - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Women's Cancer Care - Covington, Louisiana, United States
- Women's Cancer Care - Covington, Louisiana, United States
- Holy Cross Hospital - Silver Spring, Maryland, United States
- Holy Cross Hospital - Silver Spring, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Profound Research LLC/Michigan Hematology & Oncology Consultants - Dearborn, Michigan, United States
- Profound Research LLC/Michigan Hematology & Oncology Consultants - Dearborn, Michigan, United States
- David C. Pratt Cancer Center - St Louis, Missouri, United States
- David C. Pratt Cancer Center - St Louis, Missouri, United States
- Women's Cancer Center of Nevada - Las Vegas, Nevada, United States
- Women's Cancer Center of Nevada - Las Vegas, Nevada, United States
- Northwell Health - Lake Success, New York, United States
- Northwell Health - Lake Success, New York, United States
- Laura & Isaac Perlmutter Cancer Center at NYC Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Laura & Isaac Perlmutter Cancer Center at NYC Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists - Shirley, New York, United States
- North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists - Shirley, New York, United States
- Regional Medical Oncology Center - Wilson, North Carolina, United States
- Regional Medical Oncology Center - Wilson, North Carolina, United States
- Gabrail Cancer Center - Canton, Ohio, United States
- Gabrail Cancer Center - Canton, Ohio, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- University of Oklahoma - Oklahoma City, Oklahoma, United States
- Rittenhouse Hematology Oncology - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- Rittenhouse Hematology Oncology - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- AHN West Penn Hospital - Pittsburgh, Pennsylvania, United States
- AHN West Penn Hospital - Pittsburgh, Pennsylvania, United States
Showing 60 of 204 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →