NCT07141706 · DualityBio Inc.
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
What this study is about
This is a conducted at multiple hospitals, where both patients and doctors know the treatment given, multiple-dose, FIH Phase 1a/1b study.
View original scientific description
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.
Interventions
DRUG
DB-1317
Administered I.V.
Primary outcome measures
Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Time frame: up to 21 days after Cycle 1 Day 1
Percentage of participants in Phase 1a with DLTs
Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with TEAEs in Phase 1a graded according to NCI CTCAE v5.0
Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs in Phase 1a graded according to NCI CTCAE v5.0
Maximum Tolerated Dose (MTD) of DB-1317
Time frame: Up to the completion of Phase 1a (assessed up to 12 months)
MTD on the data collected during Phase 1a
Recommended Phase 1b Dose (RP2D) of DB-1317
Time frame: Up to the completion of Phase 1a (assessed up to 12 months)
RP2D of DB-1317 based on the data collected during Phase 1a
Phase 1b: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with TEAEs in Phase 1b graded according to NCI CTCAE v5.0
Phase 1b: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with SAEs in Phase 1b graded according to NCI CTCAE v5.0
Phase 1b: Objective Response Rate (ORR) as determined by investigator
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1b: Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-CRPC. The percentage of participants who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Phase 1b: duration of response (DoR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Phase 1b: disease-control rate (DCR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
DCR will be determined from tumor assessments by investigator per response
Phase 1b: Time to Response (TTR)
Time frame: Up to follow-up period, approximately 1 year post-treatment
TTR will be determined from tumor assessments by investigator per response
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Los Angeles, California
- Ann Arbor, Michigan
- Pittsburgh, Pennsylvania
- Houston, Texas
- San Antonio, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations