Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 9:29 AM
Study NCT ID:
NCT06331559
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I First-in-human, Open-label Trial to Investigate the Safety, Pharmacokinetics and Antitumor Activity of SIM0501 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.
Detailed Description:
None
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?: