A Study of QLS31905 in Patients With Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QLS31905

• Registration Number: NCT05278832
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS31905	QLS31905	QLS31905 injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	2 years	Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Objective response rate (ORR)	2 years	Objective Response Rate (ORR) is the percentage of CR+PR
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
Cmax	2 years	Maximum concentration (Cmax) of the drug after administration
AUC	2 years	The area under the curve (AUC) of serum concentration of the drug after the administration

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China