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

February 21, 2022 updated by: Qilu Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study included a screening period, a treatment period, and a post-treatment follow-up period. Safety will be monitored throughout the study. At the same time, the pharmacokinetics and immunogenicity of QL1706 and lenvatinib in subjects with advanced renal cell carcinoma were evaluated, and the preliminary efficacy of QL1706 combined with lenvatinib in subjects with advanced renal cell carcinoma was evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects participate voluntarily and sign informed consent.
  2. Male or female subjects aged 18 years or older.
  3. Pathological confirmation of renal cell carcinoma (RCC) mainly with a clear-cell component
  4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST) 1.1
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. Life expectancy of ≥6 months.
  7. The functional level of important organs must meet the requirements before the first dose of study drug.
  8. 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.
  9. 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:

  1. Symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression due to metastasis before the first dose of study drug.
  2. 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.
  3. Patients with a history of other malignant tumors within 5 years before signing the informed consent.
  4. Active autoimmune diseases that exist within 2 years prior to the first dose of study drug and require systemic treatment.
  5. Hypertension uncontrolled by 2 or more antihypertensive drugs (BP ≥150/90 mmHg at Screening).
  6. Previous history of hypertensive crisis or hypertensive encephalopathy.
  7. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation)
  8. Were receiving long-term systemic steroid therapy within 7 days prior to first dose of the study drug.
  9. 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.
  10. HbsAg and anti-HCV antibodies were positive.
  11. Patients with active pulmonary tuberculosis within one year before the first use of the investigational drug.
  12. Subjects with any of the cardiovascular diseases were excluded as defined.
  13. 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.
  14. Participants who participated in other clinical studies and used other study drugs within 4 weeks before the first dose of study drug.
  15. Known history of hypersensitivity to macromolecular protein preparation or any components of the the study drugs.
  16. Received a live vaccine within 4 weeks prior to the first dose of study drug.
  17. Major surgery within 4 weeks prior to first use of the study drug.
  18. Past and/or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severely impaired lung function, etc. may interfere with the detection and management of suspected drug-related pulmonary toxicity.
  19. Arteriovenous thromboembolic events, including cerebrovascular accident or history of stroke or transient ischemic attack, pulmonary embolism, deep vein embolism, or other serious thromboembolic events within 6 months prior to the first use of the investigational drug.
  20. Patients at risk of severe perforation or bleeding.
  21. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of the study drug.
  22. Gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to first dose of the study drug.
  23. Any life-threatening bleeding event within 3 months prior to the first trial drug, including the need for blood transfusion therapy, surgery or topical therapy, ongoing drug therapy.
  24. Concomitant treatment with therapeutic doses of anticoagulants, such as heparin, thrombin, or factor Xa inhibitors, or antiplatelet drugs.
  25. Patients who, in the investigator's judgment, may increase the risks associated with the study, may interfere with the interpretation of the study results, or are deemed unsuitable for enrollment by the investigator and/or sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QL1706 Plus Lenvatinib
QL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.
Drug: QL1706 Plus Lenvatinib
QL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.
Other Names:
  • PSB205

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Up to approximately 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QL1706-107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings