NCT06554795 · DualityBio Inc.
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
What this study is about
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
View original scientific description
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Interventions
DRUG
DB-1419
Administered Injection of Vein (I.V.)
Primary outcome measures
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)
Time frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with TEAEs graded according to NCI CTCAE v5.0
Phase 1/2a: Percentage of Participants with serious AE (SAE)
Time frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with SAEs graded according to NCI CTCAE v5.0
Phase 1a: Maximum Tolerated Dose (MTD)
Time frame: From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
MTD on the data collected during Part 1
Phase 1a: Recommended Phase 2 Dose (RP2D)
Time frame: From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.
RP2D of DB-1419 based on the data collected during Part 1
Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1
Time frame: Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
The percentage of subjects with best overall response of CR and PR
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
- Adults aged ≥ 18 years at the time of voluntarily signing informed consent. 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available. 3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor. 4. Has a life expectancy of ≥ 3 months. 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. 6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment. 7. Has adequate organ function within 7 days prior to the first dose of study treatment. 8. H
Where
- Los Angeles, California
- Newport Beach, California
- Washington D.C., District of Columbia
- Florida City, Florida
- Chicago, Illinois
- Huntersville, North Carolina
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- West Valley City, Utah
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 Jun 5, 2026 · Source of record for eligibility and locations