Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

NCT06932094 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS5132-101
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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

• Maximum tolerated dose (MTD)

  Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

  28days

• Recommended Phase 2 Dose (RP2D)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  up to 2 years

Secondary Outcomes (17)

• Maximum Serum Concentration of QLS5132 (Cmax)

  21 days

• Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)

  63 days

• Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)

  63 days

• Time of Maximum Serum Concentration of QLS5132 (Tmax)

  21 days

• Terminal Half-life (T1/2) of Serum QLS5132

  63 days

Study Arms (1)

Dose Finding and Expansion- QLS5132 Monotherapy

EXPERIMENTAL

Intravenous infusion，Q3W

Drug: QLS5132

Interventions

QLS5132 DRUG

antibody drug conjugate (ADC).

Dose Finding and Expansion- QLS5132 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, China

Location

Central Study Contacts

Tao Zhu, PhD

CONTACT

13858065156; zhutao@zjcc.org.cn

Zhengbo Song, PhD

CONTACT

13857153345; songzb@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CN (1)