Actively Recruiting
A Phase 1a/1b, Multicenter, Open-Label Study to Assess Safety, Tolerability, and Preliminary Antitumor Activity of DB-1317 in Selected Advanced or Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2026-04-09
233
Participants Needed
6
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating DB-1317, an investigational drug, in adults with selected advanced or metastatic solid tumors that have relapsed or progressed after standard treatments. This multicenter, open-label Phase 1a/1b trial aims to determine the maximum tolerated dose or maximum administered dose of DB-1317 and to further assess its safety, tolerability, and preliminary efficacy. The study focuses on solid tumors including gastric cancer, colorectal cancer, and pancreatic ductal adenocarcinoma, chosen based on tumor marker expression and unmet medical needs. The study has two parts: Phase 1a uses an accelerated titration design followed by a Bayesian optimal interval design to test up to five increasing dose levels of DB-1317 given by intravenous infusion every three weeks. Dose escalation includes careful safety monitoring with dose-limiting toxicity assessments during the first 21 days. Phase 1b involves up to three expansion cohorts, enrolling participants with specific tumor types to evaluate safety and preliminary anti-tumor activity at selected dose levels. Participants receive a single dose of DB-1317 on Day 1 of each 21-day cycle. Participants will be monitored throughout treatment cycles and followed for up to one year post-treatment. Assessments include safety evaluations such as adverse event monitoring, pharmacokinetics, tumor response measurements according to RECIST criteria, and biomarker analysis including ADAM9 expression. The study also tracks overall survival and progression-free survival. Participants must be willing to provide tumor samples and agree to contraceptive use if applicable. The total duration and follow-up periods are carefully structured to assess both short- and longer-term outcomes.
CONDITIONS
Brief Title
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults of any gender
- Have unresectable advanced or metastatic selected solid tumors that have relapsed or progressed after standard systemic treatments
- For backfilling participants in Phase 1a and all Phase 1b participants: at least one measurable tumor lesion by RECIST version 1.1; non-measurable disease allowed for CRPC participants
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before enrollment
- Willing to provide tumor samples or undergo biopsy to measure ADAM9 expression and other biomarkers if medically safe
- Agree to use adequate contraception if of reproductive or childbearing potential
You will not qualify if you...
- Prior treatment with ADAM9 targeted therapy
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors
- History of symptomatic congestive heart failure or serious cardiac arrhythmia needing treatment
- History of myocardial infarction or unstable angina within 6 months before enrollment
- Clinically important abnormalities in heart rhythm, conduction, or resting ECG
- QTcF interval prolongation greater than 470 ms
- History of non-infectious interstitial lung disease or pneumonitis
- Presence of lung-specific significant illness
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Known HIV infection, chronic or uncontrolled hepatitis B or C
- Clinically significant corneal disease
- Active brain metastases
- Unresolved toxicities from previous anticancer therapy or concurrent malignancy within past 3 years
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive intravenous doses of DB-1317 every 3 weeks in dose escalation and expansion cohorts to assess safety and preliminary antitumor activity.
1 visit every 3 weeks for dosing
Duration - Up to approximately 1 year post-treatment
Participants are monitored for safety and treatment outcomes for approximately 1 year after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 6 locations
1
USA04-0
Los Angeles, California, United States, 90025
Actively Recruiting
2
Site USA06-0
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
3
USA02-0
Houston, Texas, United States, 77030
Actively Recruiting
4
USA03-0
San Antonio, Texas, United States, 78229
Actively Recruiting
5
USA01
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
AUS01-0
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
J
Junhua Gao
M
Michael Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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