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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: QL1706 injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1706 injection; This clinical trail is a single arm study, all the patients that meet the entry criteria will receive treatment until disease progression occurs or meet other criteria for the discontinuation of treatment. QL1706 will be administered by intravenous infusion, 5 mg/kg, Q3W.	Drug: QL1706 injection; 5 mg/kg, IV, Q3w; Other Names: PSB205 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
adverse event (AE)	The rates and severity of AEs after QL1706 injection	up to 90 days after the last QL1706 injection is administered.

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Li Zhang, Doctor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QL1706-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No