Actively Recruiting
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2026-04-09
233
Participants Needed
6
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.
CONDITIONS
Official Title
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults
- Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments
- For Phase 1b and backfilling Phase 1a participants: At least one measurable lesion assessed by RECIST version 1.1; non-measurable disease allowed for CRPC participants
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance status of 0-1
- Left ventricular ejection fraction of 50% or higher within 28 days before enrollment
- Willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for ADAM9 and biomarker measurement if no contraindication
- Male and female participants of reproductive potential must agree to use adequate contraception
You will not qualify if you...
- Prior treatment with ADAM9 targeted therapy
- Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor
- History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months before enrollment
- Clinically important abnormalities in resting ECG rhythm, conduction, or morphology
- QTcF prolongation greater than 470 ms in males and females
- History of non-infectious interstitial lung disease or pneumonitis
- Lung-specific clinically significant illness
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Known HIV infection, chronic active or uncontrolled hepatitis B or C
- Clinically significant corneal disease
- Clinically active brain metastases
- Unresolved toxicities from previous anticancer therapy
- Concurrent malignancy within 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
USA04-0
Los Angeles, California, United States, 90025
Actively Recruiting
2
Site USA06-0
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
3
USA02-0
Houston, Texas, United States, 77030
Actively Recruiting
4
USA03-0
San Antonio, Texas, United States, 78229
Actively Recruiting
5
USA01
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
AUS01-0
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
J
Junhua Gao
CONTACT
M
Michael Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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