A Study of QLS5133 Monotherapy in Advanced Solid Tumors

NCT ID: NCT07061639

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-04-30

Brief Summary

The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion：

• Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion.
• Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monotherapy Dose Finding

Group Type: EXPERIMENTAL

QLS5133

Intervention Type: DRUG

antibody drug conjugate (ADC)

PK expansion as Monotherapy

Group Type: EXPERIMENTAL

QLS5133

Intervention Type: DRUG

antibody drug conjugate (ADC)

Cohort expansion as Monotherapy

Group Type: EXPERIMENTAL

QLS5133

Intervention Type: DRUG

antibody drug conjugate (ADC)

Interventions

QLS5133

antibody drug conjugate (ADC)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 years on the day of signing the ICF, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
• Measurable disease, per RECIST v1.1;
• 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, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
• Left ventricular ejection fraction (LVEF) ≥ 50%;

Exclusion Criteria

• Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
• Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
• Progressive or symptomatic brain metastases;
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
• History of significant cardiac disease, or poorly controlled diabetes mellitus;
• History of recurrent autoimmune diseases;
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (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 QLS5133 or its excipients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Central Contacts

Xiaohua Wu, PhD

Role: CONTACT

JJYIN555@163.com

021-64175590-88503

Facility Contacts

Xiaohua Wu

Role: primary

JJYIN555@163.com

021-64175590-88503

Other Identifiers

QLS5133-101

Identifier Type: -

Identifier Source: org_study_id