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Advanced Renal Cell CarcinomaPhase 1/2NCT05262413

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

A Phase 1/2 study testing QL1706 Plus Lenvatinib in people with Advanced Renal Cell Carcinoma, run by Qilu Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
QL1706 Plus Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
28 Feb 2022to 30 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Received a live vaccine within 4 weeks prior to the first dose of study drug.
  • Major surgery within 4 weeks prior to first use of the study drug.
  • 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.
  • 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.
  • Patients at risk of severe perforation or bleeding.
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of the study drug.
  • Gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to first dose of the study drug.
  • 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.
  • Concomitant treatment with therapeutic doses of anticoagulants, such as heparin, thrombin, or factor Xa inhibitors, or antiplatelet drugs.
  • 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.

About this study

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.

Read the 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.

Being tested
QL1706 Plus Lenvatinib
Keywords
QL1706

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706 Plus LenvatinibDrug

    Also called PSB205

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

Study groups in NCT05262413
Study groupRoleWhat they receive
QL1706 Plus LenvatinibExperimentalQL1706 5mg/kg administered intravenously (IV), every 3 weeks, plus Lenvatinib 20 mg or 14mg administered orally, once daily.
Receives: Drug: QL1706 Plus Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

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

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start28 Feb 2022 (estimated)
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262413
Sponsor's protocol ID
QL1706-107
Status last verified
Feb 2022
First submitted
21 Feb 2022
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing QL1706 Plus Lenvatinib in people with Advanced Renal Cell Carcinoma, run by Qilu Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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