Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 1:07 AM
Study NCT ID:
NCT03903705
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
: A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors
Sponsor:
Hutchmed
Organization:
Study Overview
Official Title:
A Phase Ib/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2025-04
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 a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors. This study includes fruquintinib plus sintilimab treatment arm (dose escalation phase and dose expansion phase), and fruquintinib monotherapy arm.
Detailed Description:
This study is composed of Fruquintinib plus sintilimab treatment arm and Fruquintinib monotherapy arm.
Fruquintinib plus sintilimab treatment arm:
* Dose escalation phase: it is planned to enroll about 26-39 patients
* Dose expansion phase: it is planned to enroll about 309-329 patients, including about 140 patients with endometrial cancer
Fruquintinib monotherapy arm: about 13 patients with advanced endometrial cancer
Fruquintinib plus sintilimab treatment arm:
* Dose escalation phase: it is planned to enroll about 26-39 patients
* Dose expansion phase: it is planned to enroll about 309-329 patients, including about 140 patients with endometrial cancer
Fruquintinib monotherapy arm: about 13 patients with advanced endometrial cancer
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: