NCT07141706 A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
| NCT ID | NCT07141706 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | DualityBio Inc. |
| Condition | Advanced/Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 253 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 253 participants in total. It began in 2025-09-23 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 one randomized dose expansion cohort and two single-arm 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 Criteria
Key Inclusion Criteria: 1. Male or female adults 2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments. 3. 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. 4. Has a life expectancy of ≥ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF ≥ 50% within 28 days before enrollment. 7. 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. 8. Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods Key Exclusion Criteria: 1. Prior treatment with ADAM9 targeted therapy. 2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor. 3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment. 4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment. 5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG 6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 ms in males and females 7. Has a history of (non-infectious) ILD/pneumonitis 8. Has a lung-specific intercurrent clinically significant illness 9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals. 10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B; 11. Known chronic, active, or uncontrolled hepatitis C 12. Has clinically significant corneal disease. 13. Has clinically active brain metastases 14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \< 3 years. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Lily Hu
STUDY DIRECTOR
DualityBio Inc.
Frequently Asked Questions
Who can join the NCT07141706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced/Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07141706 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07141706 currently recruiting?
Yes, NCT07141706 is actively recruiting participants. Contact the research team at junhua.gao@dualitybiologics.com for enrollment information.
Where is the NCT07141706 trial being conducted?
This trial is being conducted at Los Angeles, United States, Ann Arbor, United States, Pittsburgh, United States, Houston, United States and 10 additional locations.
Who is sponsoring the NCT07141706 clinical trial?
NCT07141706 is sponsored by DualityBio Inc.. The principal investigator is Lily Hu at DualityBio Inc.. The trial plans to enroll 253 participants.