A Study of QLS31905 in Patients With Advanced Solid Tumors

A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05278832

Enrollment

104

Registered

2022-03-14

Start date

2021-10-25

Completion date

2023-12-31

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Brief summary

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.

Interventions

DRUGQLS31905

QLS31905 injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Dose limiting toxicities(DLTs)	2 years	Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
Maximum tolerated Dose(MTD)	2 years	To evaluate the safety and tolerability of QLS31905

Secondary

Measure	Time frame	Description
Disease control rate (DCR)	2 years	Disease control Rate (DCR) is the percentage of CR+PR+SD
adverse events (AE)	2 years	To evaluate the safety and tolerability of QLS31905
Progression-free Survival (PFS)	2 years	Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
AUC	2 years	The area under the curve (AUC) of serum concentration of the drug after the administration
Cmax	2 years	Maximum concentration (Cmax) of the drug after administration
Objective response rate (ORR)	2 years	Objective Response Rate (ORR) is the percentage of CR+PR

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026