Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QLS5132

• Registration Number: NCT06932094
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Advanced solid tumors;
• Measurable disease, per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• Adequate organ function;
• Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;

Exclusion Criteria

• Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
• Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
• Progressive or symptomatic brain metastases;
• Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
• History of significant cardiac disease, or poorly controlled diabetes mellitus;
• History of recurrent autoimmune diseases;
• History of myelodysplastic syndrome (MDS) or AML;
• History of other active malignant tumors within 3 years before signing the informed consent form;
• If female, is pregnant or breastfeeding;
• Be allergic to any component of QLS5132 or its excipients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Finding and Expansion- QLS5132 Monotherapy	QLS5132	Intravenous infusion，Q3W

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events and serious adverse events	up to 2 years	Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Maximum tolerated dose (MTD)	28days	Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)	up to 2 years	Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Secondary Outcome Measures

Name	Time	Method
Maximum Serum Concentration of QLS5132 (Cmax)	21 days	PK assessment
Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)	63 days	PK assessment
Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)	63 days	PK assessment
Time of Maximum Serum Concentration of QLS5132 (Tmax)	21 days	PK assessment
Terminal Half-life (T1/2) of Serum QLS5132	63 days	PK assessment
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5132	21 days	PK assessment
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132	63 days	PK assessment
Volume of Distribution (Vd) of QLS5132	63 days	PK assessment
Clearance (CL) of QLS5132	63 days	PK assessment
Duration of Response (DOR)	up to 2 years	Time from CR or PR to objective disease progression or death to any cause
Objective Response Rate (ORR)	up to 2 years	Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Progression Free Survival (PFS)	up to 2 years	PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Time to Progression (TTP)	1 years	Time from start of treatment to disease progression
1 Year Overall Survival (1YOS)	up to 2 years	Proportion of participants alive at 1 year from the start of treatment to death from any cause
2 Year Overall Survival (2YOS)	2 years	Proportion of participants alive at 2 years from the start of treatment to death from any cause
Number of anti-drug antibody (ADA) Positive Participants	up to 2 years	Immunogenicity will be measured by the number of participants that are ADA positive
Number of neutralizing antibody (Nab) Positive Participants	up to 2 years	Immunogenicity will be measured by the number of participants that are Nab positive

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China