Clinical trial NCT05171790: A Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Solid Tumors
Official title: A Multicenter, Open Phase 1b Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: disease control rate (DCR)
timeFrame: up to 24 weeks
measure: progression-free survival (PFS)
timeFrame: 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
measure: overall survival time (OS)
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 24 months
measure: adverse event (AE)
timeFrame: up to 90 days after the last QL1706 injection is administered.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: