RecruitingPhase 1NCT07141706

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors

Sponsor

DualityBio Inc.

Enrollment

233 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced/Metastatic Solid Tumors

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria14

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.