Phase Ib/II Clinical Study of QLS5133 Combination Therapy in Advanced Solid Tumors

November 6, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5133 Combination Therapy in Participants With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5133 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.

The main questions it aims to answer are:

  • In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5133 combination therapy, and what are the recommended dose(s) for expansion?
  • In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5133 combination therapy at the selected dose(s) in participants with specific tumor types?

Participants will:

  • Be enrolled in sequential cohorts to receive QLS5133 in combination with other anticancer agents.
  • Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
558

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Cancer Hospital of Shandong First Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed advanced solid tumors, with specific tumor type and prior treatment requirements per each cohort;
  • 2. Measurable disease per RECIST v1.1 (except Cohorts 3B-1, 3B-2, and 5B);
  • 3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • 4.Adequate organ function;
  • 5.Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v6.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;.

Exclusion Criteria:

  • 1.Prior treatment with CDH6-targeted agents or topoisomerase I inhibitors (including ADCs);
  • 2.Prior treatment with immune checkpoint inhibitors (for Cohorts 2 and 6 only);
  • 3.Prior Grade 4 or persistent ≥ 4-week Grade 3 immune-related AEs from immune checkpoint inhibitors;
  • 4.Prior systemic anti-tumor therapy (for Cohorts 1B-2 and 2B-2 only);
  • 5.Recent anti-tumor therapy within specified washout periods (small molecules: 2 weeks; biologics/chemotherapy: 4 weeks; mitomycin/nitrosoureas: 6 weeks);
  • 6.Active or symptomatic CNS metastases or leptomeningeal carcinomatosis;
  • 7. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
  • 8.History of significant cardiac disease, or poorly controlled diabetes mellitus;
  • 9.History of recurrent autoimmune diseases;
  • 10. History of a second primary malignancy;
  • 11.Be allergic to any component of QLS5133 or its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1

QLS5133 in combination with lenvatinib mesylate
Drug: QLS5133; Lenvatinib mesylate

QLS5133: Intravenous infusion, Q3W; Lenvatinib mesylate: Oral, once daily
Experimental: Arm 2

QLS5133 in combination with lenvatinib mesylate plus QL2107
Drug: QLS5133; QL2107; Lenvatinib mesylate

QLS5133 and QL2107: Intravenous infusion, Q3W; Lenvatinib mesylate: Oral, once daily
Experimental: Arm 3

QLS5133 in combination with bevacizumab
Drug: QLS5133; Bevacizumab

Intravenous infusion，Q3W
Experimental: Arm 4

QLS5133 in combination with platinum-based therapy with or without bevacizumab, followed by QLS5133 alone or in combination with bevacizumab
Drug: QLS5133; Platinum; Bevacizumab

Intravenous infusion，Q3W
Experimental: Arm 5

QLS5133 in combination with olaparib with or without bevacizumab
Drug: QLS5133; Olaparib; Bevacizumab

Olaparib is oral; all others are intravenous infusion，Q3W
Experimental: Arm 6

QLS5133 in combination with QL2107 with or without bevacizumab
Drug: QLS5133; QL2107; Bevacizumab

Intravenous infusion，Q3W

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase Ib Outcome 1:Incidence and severity of adverse events and serious adverse events
Time Frame: up to 2 years

Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 6.0
up to 2 years
Phase Ib Outcome 2:Maximum tolerated dose (MTD)
Time Frame: 28 days

Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
28 days
Phase Ib Outcome 3:Recommended Phase 2 Dose (RP2D)
Time Frame: up to 2 years

Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
up to 2 years
Phase II outcome 1:Objective response rate (ORR) (Arms 1B, 2B, 3B-3, 4B, 6B)
Time Frame: up to 2 years

ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
up to 2 years
Phase II outcome 2:Progression-free survival (PFS) (Arms 3B-1, 3B-2, and 5B)
Time Frame: up to 2 years

PFS is defined as the duration from the date of first dose of study treatment to the date of first documented PD per investigator assessment, or death from any cause, whichever occurs first.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QLS5133-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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