Trials / Withdrawn
WithdrawnNCT05099536
3D011-08 Monotherapy in Subjects With Advanced Solid Tumors
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
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- 3D Medicines (Beijing) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Detailed Description: This study was initiated on February 24, 2022, at Fudan Cancer Hospital. However, noparticipants were screened or enrolled after the initiation. Due to strategic development adjustments, thecompany terminated the study on September 11. 2023.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 3D011-08 | 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). |
Timeline
- Start date
- 2022-02-24
- Primary completion
- 2023-09-11
- Completion
- 2023-09-11
- First posted
- 2021-10-29
- Last updated
- 2024-01-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05099536. Inclusion in this directory is not an endorsement.