A Study of QLS31905 in Patients With Advanced Solid Tumors

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: QLS31905

Study type: Interventional

Funder types: Industry

Identifiers

NCT05278832

QLS31905-101

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

QLS31905

Experimental group

Description:

QLS31905 injection

Treatment:

Drug: QLS31905