Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

June 1, 2024 updated by: Qilu Pharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

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.
360

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

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects voluntarily participate in the study and sign the informed consent form;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • Expected survival time ≥ 3 months;
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
  • No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
  • Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
  • At least one measurable lesion per RECIST v1.1;
  • Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria:

  • History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
  • Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
  • Known central nervous system metastases;
  • Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
  • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

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: QLS31905 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Drug: Capecitabine
1000 mg/m2, oral, bid, D1-D14
Experimental: QL1706 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
Drug: Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Drug: Capecitabine
1000 mg/m2, oral, bid, D1-D14
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Experimental: QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Drug: Capecitabine
1000 mg/m2, oral, bid, D1-D14
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Experimental: QLS31905 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Drug: Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
Experimental: QL1706 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Drug: Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Drug: Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
Experimental: QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Drug: Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Drug: Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
Experimental: QLS31905 + standard chemotherapy
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: Chemotherapy drug
Standard chemotherapy recommended by guidelines.
Experimental: QL1706 + standard chemotherapy
Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Drug: Chemotherapy drug
Standard chemotherapy recommended by guidelines.
Experimental: QLS31905 + standard chemotherapy + QL1706
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
Drug: QLS31905
Administered as an intravenous infusion.
Drug: QL1706
5 mg/kg, intravenous infusion,D1
Drug: Chemotherapy drug
Standard chemotherapy recommended by guidelines.

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
Objective response rate (ORR)
Time Frame: Approximately 24 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)
Approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety assessed by Adverse Events (AEs)
Time Frame: Approximately 24 months
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Approximately 24 months
Safety assessed by incidence of serious adverse events (SAE)
Time Frame: Approximately 24 months
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.
Approximately 24 months
Number of participants with laboratory value abnormalities
Time Frame: Approximately 24 months
Number of participants with potentially clinically significant laboratory values.
Approximately 24 months
Duration of Response (DOR)
Time Frame: Approximately 24 months
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).
Approximately 24 months
Progression Free Survival(PFS)
Time Frame: Approximately 24 months
PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).
Approximately 24 months
Overall Survival (OS)
Time Frame: Approximately 24 months
OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
Approximately 24 months
Maximum concentration (Cmax)
Time Frame: Approximately 24 months
Cmax will be derived from the PK serum samples collected.
Approximately 24 months
Time of the maximum concentration (Tmax)
Time Frame: Approximately 24 months
Tmax will be derived from the PK serum samples collected.
Approximately 24 months
Terminal elimination half-life (T1/2)
Time Frame: Approximately 24 months
T1/2 will be derived from the PK serum samples collected.
Approximately 24 months
Clearance (CL)
Time Frame: Approximately 24 months
CL will be derived from the PK serum samples collected.
Approximately 24 months
Apparent volume of distribution during the terminal phase (Vz)
Time Frame: Approximately 24 months
Vz will be derived from the PK serum samples collected.
Approximately 24 months
Number of anti-drug antibody (ADA) Positive Participants
Time Frame: Approximately 24 months
Immunogenicity will be measured by the number of participants that are ADA positive.
Approximately 24 months

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.
June 30, 2024

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.
June 30, 2026

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.
December 1, 2027

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).
June 1, 2024

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.
June 1, 2024

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.
June 6, 2024

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.
June 6, 2024

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.
June 1, 2024

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.
May 1, 2024

More Information

Terms related to this study

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.
  • QLS31905-202

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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