Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05055518
Status:
SUSPENDED
Last Update Posted:
2025-06-27
First Post:
2021-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
APL-102 Capsule in Patients With Advanced Solid Tumors
Sponsor:
Apollomics Inc.
Organization:
Study Overview
Official Title:
Phase I Study on Safety, Tolerance, and Pharmacokinetics of APL-102 Capsule in Patients With Advanced Solid Tumors
Status:
SUSPENDED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Voluntarily suspended (due to adjustments in corporate development strategy, not for reasons related to safety or efficacy.)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and tolerability of APL-102 Capsule and characterize the pharmacokinetic (PK) profile in advanced solid tumor patients.
Detailed Description:
This study is an open, multicenter dose-escalation study to evaluate the safety and tolerance of APL-102 and obtain the relevant data of APL-102 in patients with advanced solid tumors. In the dose escalation stage, based on the incidence of dose limited toxicity (DLT) and adverse event (AE), explore and determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D). After RP2D and administration protocol are determined, an extended study will be conducted on 6-10 subjects to further evaluate the safety and antitumor activity of APL-102.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: