drugset / Trial / NCT03934359

A Study to Evaluate the Safety, Tolerability of DN1508052-01 in Advanced Solid Tumors

NCT03934359 ↗

Phase 1 Completed 19 enrolled Shanghai De Novo Pharmatech Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I, open-label, multicenter study in adult patients with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists. DN1508052-01 will be administered subcutaneously on Day 1, Day 8 and Day 15 in 28-day cycles. Other dose regimens may be explored based on the analysis of emerging PK, pharmacodynamics (PD) and safety data. This study is designed to determine the MTD, RP2D and investigate the safety, tolerability, PK, biomarkers, HPV status and ISR in DN1508052-01-treated patients.

Timeline

Start
2019-09-18
Primary completion
2022-08-30
Completion
2022-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject DN1508052-01 Unknown 0.01 mg/m2 Subcutaneous
Subject DN1508052-01 Unknown 0.1 mg/m2 Subcutaneous

Indications