Brief Summary
A Phase 1/2a First-in-Human Study of DB-1419 in Advancedat a late stage, far along/Metastatic Solid Tumors
Intervention / Treatment
- Drug: DB-1419
Inclusion Criteria:
- Adults aged ≥ 18 years at the time of voluntarily signing informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- 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.
- 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 Monitorto check on, keep track of.
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) of 0-1.
- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Has adequate organ function within 7 days prior to the first dosethe amount of medication taken of study treatment.
- Has adequate treatment washout period prior to the first dose of study treatment.
- Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells if feasible for the measurement of B7-H3/PD-L1 level and other biomarkers if no contraindication.Note: there is no minimum B7-H3/PD-L1 expression level mandatory for entry into the study.
- Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.