Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 5:38 AM
Study NCT ID:
NCT06932094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
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:
The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):
* Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
* Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.
* Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
* Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: