A Study of QLS5133 Monotherapy in Advanced Solid Tumors

NCT07061639 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS5133-101
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (16)

• Maximum Serum Concentration of QLS5133 (Cmax)

  21 days

• Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss)

  63 days

• Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss)

  63 days

• Time of Maximum Serum Concentration of QLS5133 (Tmax)

  21 days

• Terminal Half-life (T1/2) of Serum QLS5133

  63 days

Study Arms (3)

Monotherapy Dose Finding

EXPERIMENTAL

Drug: QLS5133

PK expansion as Monotherapy

EXPERIMENTAL

Drug: QLS5133

Cohort expansion as Monotherapy

EXPERIMENTAL

Drug: QLS5133

Interventions

QLS5133 DRUG

antibody drug conjugate (ADC)

Cohort expansion as Monotherapy; Monotherapy Dose Finding; PK expansion as Monotherapy

Eligibility Criteria

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

You may qualify if:

• 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%;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Central Study Contacts

Xiaohua Wu, PhD

CONTACT

021-64175590-88503; JJYIN555@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)