A Phase 1/2a Study of DB‑1303/BNT323 in Advanced/Metastatic Solid Tumors
Trial status:Recruiting
Trial ID:
DB-1303-O-1001
NCT ID:
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
DualityBio Inc.
Recruiting
Trial Details
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.
Medical Condition
Trial Drug
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Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
796
Estimated Trial Date
Jan 2022 - Apr 2026
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
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.
- 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.
Inclusion Criteria:
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:
Trial Locations
Location
Status
Location
Helios Clinical Research
Cerritos, California, United States, 90703
Status
Active, not recruiting
Location
California Research Institute
Los Angeles, California, United States, 90027
Status
Active, not recruiting
Location
Sharp Memorial Hospital
San Diego, California, United States, 92123
Status
Active, not recruiting
Location
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Status
Active, not recruiting
Location
Advanced Research LLC
Coral Springs, Florida, United States, 33065
Status
Active, not recruiting
Location
The Oncology Institute of Hope and Innovation
Lakeland, Florida, United States, 33812
Status
Active, not recruiting
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