CI

At a glance

ClinicalIndex Comparison Record
Phase 1Withdrawn· 0 enrolled
Drug / intervention
3D011-08drug
Likely dose
3D011-08 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05099536
NCT05099536Phase 1Withdrawn
Withdrawn
CompareCT.gov

A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D011-08 for Injection Monotherapy in Subjects With Advanced Solid Tumors

3D Medicines (Beijing) Co., Ltd.·interventional·Posted Oct 29, 2021·Updated Jan 31, 2024

In Brief

A Phase 1 clinical trial evaluating 3D011-08 for Solid Tumor, Adult. Withdrawn before enrollment, across 1 site.

Signals

Trial was withdrawn before enrollment

Detailed Summary

The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Adult
CountriesChina
Collaborators--

Timeline

Phase 1WithdrawnFinished
20222023202420252026
First PostedOct 29, 2021
Enrollment StartFeb 24, 2022
Primary CompletionSep 11, 2023
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 4.7 years ago

Interventions

3D011-08drug

participants will receive 15mg (starting dose)intravenous drop of 3D011-08,All subjects in each cohort will receive a single dose of 3D011-08 first, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive doses on 1,3,5day of each week (28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first.Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RPTD).