Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
Study NCT ID:
NCT03934359
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2019-04-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability of DN1508052-01 in Advanced Solid Tumors
Sponsor:
Shanghai De Novo Pharmatech Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ⅰ, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of DN1508052-01 as a Single Agent When Administered Subcutaneously to Adult Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Study Population is adult patients (≥18 years) with histologically or cytologically confirmed, unresectable advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.The selected starting dose, 0.01 mg/m2 of DN1508052-01, SC, on Day 1, Day 8 and Day 15 of each cycle.The starting dose will proceed with one patient. The next dose 0.1 mg/m2 will be explored if safety data permit in that there is no instance of a ≥ Common Terminology Criteria for Adverse Event (CTCAE v5.0) Grade 2 AE that is at least possibly related to the study intervention.then Dose escalation will then proceed following the 3+3 cohorts design.Dose escalation will continue until MTD or RP2D is reached, or the dose escalation will be terminated at the discretion of Investigators and Sponsor (or its designee) based on the analyses of emerging PK, PD, safety and efficacy data.The Primary objective is to determine the maximum tolerated dose (MTD) and recommended phase Ⅱ dose (RP2D) and assess dose-limiting toxicity (DLT) of DN1508052-01 as a single agent when administered subcutaneously to adult patients with advanced solid tumors.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: