A Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Multicenter, Open Phase 1b Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Advanced Malignant Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05171790
• Other study ID #: QL1706-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 11, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This a multi-center, open-label, non-randomized phaseⅠb trail. The purpose of this study was to evaluate the efficacy and safety of QL1706 in patients with advanced solid tumors and to investigate the immunogenicity and pharmacokinetic characteristics of QL1706.

Description:

The study was divided into screening/baseline, treatment and follow-up periods. Efficacy assessment and safety monitoring will be conducted throughout the study period.

Subjects will continue study treatment until disease progression occurs (unless the investigator believes there is a sustained clinical benefit) or other criteria for discontinuing study treatment are met, whichever occurs first.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 419
• Est. completion date: December 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects participate voluntarily and sign informed consent.

• Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors,such as lung cancer, nasopharyngeal carcinoma, cervical cancer, hepatocellular carcinoma, kidney cancer etc., failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery

• Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.

• Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.

• The extension of life is more than 3 months

• Vital organs' function is adequate for enrolling

• Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.

• Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to =1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.

Exclusion Criteria:

• Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.

• There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.

• Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.

• Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study

• Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period

• Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.

• Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs

• Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• QL1706 injection
5 mg/kg, IV, Q3w

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

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	objective response rate (ORR)	ORR includes complete response (CR) and partial response (PR) cases. According to RECIST V1.1, the first appearance of PR or CR requires additional imaging to confirm the lesion at =4 weeks.	up to 24 weeks
Secondary	disease control rate (DCR)	DCR refers to the percentage of the cases in which the best efficacy rating is complete response (CR) or partial response (PR) or stable disease (SD).	up to 24 weeks
Secondary	progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time between a subject's first infusion QL1706 injection and their first radiographic evaluation of disease progression or death from any cause, whichever comes first.	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	overall survival time (OS)	Overall survival (OS) is the time between the subject's first infusion QL1706 injection and death from any cause.	From date of enrollment until the date of death from any cause, assessed up to 24 months
Secondary	adverse event (AE)	The rates and severity of AEs after QL1706 injection	up to 90 days after the last QL1706 injection is administered.