A Study of QL1706 Plus Lenvatinib in Subjects With Advanced Renal Cell Carcinoma(RCC)

NCT05262413 | Unknown Phase 1

• 1 other identifier: QL1706-107
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 1b, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of QL1706 plus lenvatinib in subjects with advanced RCC.

Conditions

Advanced Renal Cell Carcinoma

Keywords

QL1706

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0

  Up to approximately 2 years

Study Arms (1)

QL1706 Plus Lenvatinib

EXPERIMENTAL

QL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.

Drug: QL1706 Plus Lenvatinib

Interventions

QL1706 Plus Lenvatinib DRUG

QL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.

Also known as: PSB205

QL1706 Plus Lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects participate voluntarily and sign informed consent.
• Male or female subjects aged 18 years or older.
• Pathological confirmation of renal cell carcinoma (RCC) mainly with a clear-cell component
• At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST) 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy of ≥6 months.
• The functional level of important organs must meet the requirements before the first dose of study drug.
• Male and female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose. Female subjects who are not 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.

You may not qualify if:

• Symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression due to metastasis before the first dose of study drug.
• Received radiotherapy or other local treatment within 2 weeks before the first dose of study drug, and did not recover from the adverse reactions of local treatment.
• Patients with a history of other malignant tumors within 5 years before signing the informed consent.
• Active autoimmune diseases that exist within 2 years prior to the first dose of study drug and require systemic treatment.
• Hypertension uncontrolled by 2 or more antihypertensive drugs (BP ≥150/90 mmHg at Screening).
• Previous history of hypertensive crisis or hypertensive encephalopathy.
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation)
• Were receiving long-term systemic steroid therapy within 7 days prior to first dose of the study drug.
• HIV-positive patients; known to have received anti-tuberculosis therapy within one year before the first study treatment; hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU/ml or 104 copies/ml ; HCV antibody positive and HCV RNA positive.
• HbsAg and anti-HCV antibodies were positive.
• Patients with active pulmonary tuberculosis within one year before the first use of the investigational drug.
• Subjects with any of the cardiovascular diseases were excluded as defined.
• The patient is known to have a history of psychotropic substance abuse, alcoholism, or drug use; a clear history of neurological or psychiatric disorders, including epilepsy or dementia or hepatic encephalopathy.
• Participants who participated in other clinical studies and used other study drugs within 4 weeks before the first dose of study drug.
• Known history of hypersensitivity to macromolecular protein preparation or any components of the the study drugs.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

lenvatinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: February 28, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02