Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

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

Overview

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.

Interventions

• Drug QLS5132
  antibody drug conjugate (ADC).

Primary outcome measures

• Incidence and severity of adverse events and serious adverse events [Time frame: up to 2 years]
• Maximum tolerated dose (MTD) [Time frame: 28days]
• Recommended Phase 2 Dose (RP2D) [Time frame: up to 2 years]

Secondary outcome measures (12)

• Maximum Serum Concentration of QLS5132 (Cmax) [Time frame: 21 days]
• Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss) [Time frame: 63 days]
• Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss) [Time frame: 63 days]
• Time of Maximum Serum Concentration of QLS5132 (Tmax) [Time frame: 21 days]
• Terminal Half-life (T1/2) of Serum QLS5132 [Time frame: 63 days]
• Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5132 [Time frame: 21 days]
• Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132 [Time frame: 63 days]
• Volume of Distribution (Vd) of QLS5132 [Time frame: 63 days]
• Clearance (CL) of QLS5132 [Time frame: 63 days]
• Objective Response Rate (ORR) [Time frame: up to 2 years]
• Duration of Response (DOR) [Time frame: up to 2 years]
• Progression Free Survival (PFS) [Time frame: up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06932094 · QLS5132-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗