Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: QLS5132

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tao Zhu, PhD; Phone Number: 13858065156; Email: zhutao@zjcc.org.cn
• Study Contact Backup: Name: Zhengbo Song, PhD; Phone Number: 13857153345; Email: songzb@zjcc.org.cn

Study Locations

• China
  • Hangzhou, China
    • Zhejiang Cancer Hospital
    • Contact: Tao Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Finding and Expansion- QLS5132 Monotherapy; Intravenous infusion，Q3W	Drug: QLS5132; antibody drug conjugate (ADC).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QLS5132-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No