A Study of QLS31905 in Patients With Advanced Solid Tumors

NCT ID: NCT05278832

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QLS31905

QLS31905 injection

Group Type EXPERIMENTAL

QLS31905

Intervention Type DRUG

QLS31905 injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QLS31905

QLS31905 injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written informed consent.
2. ≥18 years.
3. Female or male.
4. ECOG performance status score 0 or 1.
5. Histologically or cytologically confirmed diagnosis of advanced solid tumors.
6. Adequate haematological, hepatic and renal function.

Exclusion Criteria

1. Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
2. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
3. Patients with a history of monoclonal antibody allergic reaction.
4. Known human immunodeficiency virus infection or known symptomatic hepatitis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lin Shen

Role: primary

010-881965671

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QLS31905-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of QLS5133 Monotherapy in Advanced Solid Tumors
NCT07061639 NOT_YET_RECRUITING PHASE1/PHASE2
Study in Advanced Solid Tumor Patients
NCT07300943 NOT_YET_RECRUITING PHASE1/PHASE2