A Study of QLS31905 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278832
• Other study ID #: QLS31905-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• QLS31905
QLS31905 injection

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities(DLTs)	Number of participants experiencing DLTs According to NCI-CTCAE v.5.0,To evaluate the safety and tolerability of QLS31905	2 years
Primary	Maximum tolerated Dose(MTD)	To evaluate the safety and tolerability of QLS31905	2 years
Secondary	Progression-free Survival (PFS)	Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.	2 years
Secondary	Objective response rate (ORR)	Objective Response Rate (ORR) is the percentage of CR+PR	2 years
Secondary	Disease control rate (DCR)	Disease control Rate (DCR) is the percentage of CR+PR+SD	2 years
Secondary	adverse events (AE)	To evaluate the safety and tolerability of QLS31905	2 years
Secondary	Cmax	Maximum concentration (Cmax) of the drug after administration	2 years
Secondary	AUC	The area under the curve (AUC) of serum concentration of the drug after the administration	2 years