Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04221204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2019-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Monotherapy in Subjects With Advanced Solid Tumors
Sponsor:
3D Medicines (Beijing) Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D185 Monotherapy in Subjects With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics Profiles, and Preliminary Efficacy of 3D185 Monotherapy in Subjects with Advanced Solid Tumors
Detailed Description:
Subjects with advanced solid tumors who have no available standard therapy or who have failed standard therapies.
This is an open-label, global multicenter, dose-escalation phase 1 study of safety, tolerability, preliminary PK profile, and preliminary efficacy of 3D185 capsules monotherapy in subjects with advanced solid tumors.
The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
This is an open-label, global multicenter, dose-escalation phase 1 study of safety, tolerability, preliminary PK profile, and preliminary efficacy of 3D185 capsules monotherapy in subjects with advanced solid tumors.
The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
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?:
False
Is an FDA AA801 Violation?: