Clinical trial NCT06047431: A Study of QL1706H in Patients With Advanced Solid Tumors
Official title: A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase Ⅰ study of QL1706H in patients with advanced solid tumors. The study will evaluate the pharmacokenetics, safety, tolerability and preliminary efficacy of QL1706H.

Detailed description: The study is composed of 2 parts. Part 1 is a dose-escalation study to explore the pharmacokenetics (PK), safety, and tolerability of QL1706H. Part 2 of the study will explore the PK characteristics of differente intervals and sites of administration. All the PK parameters will determine the recommended Phase 2 dose (RP2D).

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

Eligibility criteria: Inclusion Criteria:

* Subjects participate voluntarily and sign informed consent.
* Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, 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: Minimum Serum Drug Concentration ( Ctrough)
timeFrame: one cycle (3 weeks)
Secondary outcomes:
measure: Safety and tolerability
timeFrame: one cycle (3 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Cancer Hospital
name: Wei Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: