OncoMatch/Clinical Trials/NCT05785741
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
Is NCT05785741 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DB-1310 and Trastuzumab for advanced solid tumor.
Treatment: DB-1310 · Trastuzumab · Osimertinib — 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
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ERBB3 expression (measurement required; no eligibility threshold specified)
willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of HER3 level and other biomarkers
Allowed: HER2 (ERBB2) IHC 0
For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample
Disease stage
Metastatic disease required
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced/unresectable or metastatic
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 trastuzumab deruxtecan 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 trastuzumab deruxtecantopoisomerase 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
Blood counts
adequate organ functions within 7 days prior to day 1 of cycle 1
Kidney function
adequate organ functions within 7 days prior to day 1 of cycle 1
Liver function
adequate organ functions within 7 days prior to day 1 of cycle 1
Cardiac function
lvef ≥ 50% by either echocardiography (echo) or multiple-gated acquisition (muga) within 28 days before enrollment
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
- D&H Cancer Research Center LLC · Margate, Florida
- Sarah Cannon Research Institute at Florida Cancer Specialists · Orlando, Florida
- BRCR global · Plantation, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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