Status:
RECRUITING
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Lead Sponsor:
DualityBio Inc.
Conditions:
Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 t...
Detailed Description
Phase 1a (Dose Escalation and Backfilling) Approximately 5 increasing dose levels of DB-1317 dosing every 3 weeks (Q3W) will be evaluated using an accelerated titration design at the first dose level...
Eligibility Criteria
Inclusion
- Key
- Male or female adults
- Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
- Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
- Has a life expectancy of ≥ 3 months.
- Has an ECOG PS of 0-1.
- Has LVEF ≥ 50% within 28 days before enrollment.
- Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.
- Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods
- Key
Exclusion
- Prior treatment with ADAM9 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
- Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
- Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
- Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 ms in males and females
- Has a history of (non-infectious) ILD/pneumonitis
- Has a lung-specific intercurrent clinically significant illness
- Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
- Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;
- Known chronic, active, or uncontrolled hepatitis C
- Has clinically significant corneal disease.
- Has clinically active brain metastases
- Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \< 3 years.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT07141706
Start Date
September 23 2025
End Date
June 1 2028
Last Update
December 19 2025
Active Locations (4)
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1
USA02-0
Houston, Texas, United States, 77030
2
USA03-0
San Antonio, Texas, United States, 78229
3
USA01
Fairfax, Virginia, United States, 22031
4
AUS01-0
Randwick, New South Wales, Australia, 2031