OncoMatch/Clinical Trials/NCT05785741
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
Is NCT05785741 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including DB-1310 and Trastuzumab for advanced solid tumor.
Treatment: DB-1310 · Trastuzumab · Osimertinib · capecitabine — This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced/unresectable or metastatic solid tumor
relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
Cannot have received: HER3-targeted therapy
Prior treatment with HER3 targeted therapy
Cannot have received: antibody drug conjugate with topoisomerase I inhibitor
Exception: except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1
Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1)
Lab requirements
Cardiac function
LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment. No symptomatic CHF (NYHA II-IV), serious arrhythmia, recent MI/unstable angina/CVA/TIA within 6 months, uncontrolled hypertension, or significant ECG abnormalities.
Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment. Has a medical history of symptomatic congestive heart failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia requiring treatment. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg). Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms). Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- UCLA Hematology/Oncology - Santa Monica · Santa Monica, California
- Research Site 117 · Coral Gables, Florida
- D&H Cancer Research Center LLC · Margate, Florida
- Sarah Cannon Research Institute at Florida Cancer Specialists · Orlando, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05785741 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER3-targeted therapy, antibody drug conjugate with topoisomerase I inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify