Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors | Drug: DN1508052-01 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A phase Ⅰ,multi-center, open-label |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 18, 2019 |
Estimated Primary Completion Date : | August 30, 2020 |
Estimated Study Completion Date : | August 30, 2021 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 28, 2019 | ||||
First Posted Date ICMJE | May 1, 2019 | ||||
Last Update Posted Date | December 5, 2019 | ||||
Actual Study Start Date ICMJE | September 18, 2019 | ||||
Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the maximum tolerated dose (MTD) [ Time Frame: 28 days ] MTD is the highest dose of DN1508052-01 in subjects with DLT less than 33.3% during the DLT observation in the dose escalation
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Safety, Tolerability of DN1508052-01 in Advanced Solid Tumors | ||||
Official Title ICMJE | 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 | ||||
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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: A phase Ⅰ,multi-center, open-label Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE | Drug: DN1508052-01
DN1508052-01 will be administered subcutaneously on Day 1, Day 8 and Day 15 of each cycle.
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Study Arms ICMJE | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 30, 2021 | ||||
Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03934359 | ||||
Other Study ID Numbers ICMJE | DN1508052-01-101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Shanghai De Novo Pharmatech Co., Ltd. | ||||
Study Sponsor ICMJE | Shanghai De Novo Pharmatech Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Shanghai De Novo Pharmatech Co., Ltd. | ||||
Verification Date | November 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |