AzTrials
AzTrials

Kidney CancerPhase 1/2NCT06577961

Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

A Phase 1/2 study testing Vorolanib and cadonilimab in people with Kidney Cancer and RCC, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Cancer, RCC, Renal Cell Carcinoma
What is being tested?
Vorolanib and cadonilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
No sites listed yet
Study dates
31 Aug 2024to 31 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participate in this study, willing and able to comply with and sign the informed consent form;
  • Histologically confirmed clear cell renal cell carcinoma;
  • Advanced (not suitable for curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC;
  • No prior systemic treatment for RCC, except for the following situations:
  • For completely resectable renal cell carcinoma, having received one type of adjuvant or neoadjuvant treatment, if the treatment does not include drugs targeting VEGF or VEGFR, and recurrence occurs at least 6 months after the last adjuvant or neoadjuvant treatment;
  • Confirmed to have at least one measurable lesion according to RECIST 1.1 criteria;
Show all 16Show fewer
  • KPS score ≥ 70;
  • Expected survival time of more than 3 months;
  • Aged 18-75 years;
  • Good function of major organs and sufficient hematology, meeting the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/μL (no granulocyte colony-stimulating factor support within 2 weeks before Cycle 1, Day 1) Platelet count (PLT) ≥ 80 × 10^9/L. WBC count ≥ 2500/μL without G-CSF, ≤ 15000/μL Lymphocyte count ≥ 500/μL Hemoglobin ≥ 9.0 g/dL (Cycle 1), not dependent on erythropoietin, and no transfusion of concentrated red blood cells (pRBC) in the past 2 weeks Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN) (liver metastasis ≤ 5 times ULN). If the patient has bone metastasis, ALP ≤ 5 times ULN.
  • Serum bilirubin ≤ 1.5 × ULN. Patients with known Gilbert's syndrome can be enrolled if serum bilirubin level ≤ 3 times ULN.
  • Serum albumin ≥ 2.8 g/dL Creatinine ≤ 2.0 × ULN or calculated creatinine clearance rate ≥ 30 mL/min. Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol)
  • For women who are not menopausal (amenorrhea for 12 months) or surgically sterile (without ovaries and/or uterus): agree to use two appropriate methods of contraception, including at least one method with an annual failure rate of ≥ 1%.
  • Sexually active subjects of childbearing potential and their partners must agree to use medically recognized contraceptive methods during the study and for 5 months after the last dose of study treatment for women and 7 months for men (e.g., barrier methods, including male condoms, female condoms, or diaphragms coated with spermicidal gel).
  • Female subjects of childbearing potential must not be pregnant at screening. Women of childbearing potential are defined as premenopausal women who can become pregnant (i.e., women who have had any menstrual signs in the past 12 months, except for those who are surgically sterile as mentioned above).However, women who have been amenorrheic for 12 months or longer are still considered to have childbearing potential if the amenorrhea is likely due to previous chemotherapy, anti-estrogens, low body weight, ovarian suppression, or other reasons.

Who cannot join

  • Received any systemic treatment for RCC, unless the investigator can provide evidence that the subject has been randomly assigned to the placebo group;
  • Central nervous system metastasis;
  • Active malignant tumor in the past 24 months (except for renal cell carcinoma, skin basal cell carcinoma or squamous cell carcinoma that has been clearly treated, as well as cervical or bladder carcinoma in situ). Participants with a history of localized and low-risk prostate cancer who have received curative treatment and have not had a prostate-specific antigen (PSA) recurrence in the past 5 years may participate in the study;
  • Received prior radiotherapy within 21 days before the start of study treatment (palliative radiotherapy for bone lesions is allowed, provided it is completed at least 2 weeks before the start of study treatment);
  • Currently participating in another study or received study drugs within 4 weeks before the start of study treatment.
  • Receiving live vaccines within 30 days after the planned start of study treatment (first cycle/day 1). Live vaccines include but are not limited to measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal influenza vaccines are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines are attenuated live vaccines and are not allowed.
Show all 31Show fewer
  • Participants with proteinuria > 1+ on urine dipstick test will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Participants with urinary protein ≥ 1g/24h will not be eligible.
  • Fasting total cholesterol > 300 mg/dL (or 7.75 mmol/L) and/or fasting triglyceride level 2.5 times the upper limit of normal (ULN). Note: These participants can be included after lipid-lowering treatment.
  • Uncontrolled diabetes defined as fasting blood glucose > 1.5 times the upper limit of normal. Note: These participants can be included after hypoglycemic treatment.
  • Uncontrolled hypercalcemia (≥ 1.5 mmol/L ionized calcium or Ca ≥ 12 mg/dL or corrected serum calcium ≥ ULN) or symptomatic hypercalcemia requiring continued bisphosphonate treatment or denosumab.
  • QTc interval prolongation to > 480 ms.
  • Participants who have not fully recovered from any toxicity and/or complications caused by major surgery before starting treatment.
  • Malabsorption, gastrointestinal anastomosis, or any other condition that may affect the absorption of study drugs.
  • Clinically significant hematuria, vomiting blood, or coughing up blood > 0.5 teaspoon (2.5 ml) within 12 weeks before the first dose, or other significant bleeding history (such as pulmonary hemorrhage).
  • Significant cardiovascular impairment within 12 months after the first dose of study drug: history of congestive heart failure New York Heart Association class II or higher, unstable angina, myocardial infarction, cerebrovascular accident, or arrhythmia related to hemodynamic instability. The following conditions are also excluded: left ventricular ejection fraction (LVEF) below the institutional normal range determined by gated blood pool scan or echocardiogram.
  • Active infection (any infection requiring systemic treatment).
  • Positive for human immunodeficiency virus (HIV).
  • Active hepatitis B or C.
  • Known history of interstitial lung disease or any evidence.
  • History of (non-infectious) pneumonia requiring steroids, or currently suffering from pneumonia.
  • Diagnosed with immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first study treatment. Physiological doses of corticosteroids (up to 10 mg/day prednisone or equivalent) can be used during the study period.
  • Active autoimmune disease requiring systemic treatment within the past 2 years (excluding psoriasis). Alternative therapies (such as thyroid hormones, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered forms of systemic treatment.
  • Breastfeeding or pregnant women at screening or baseline.
  • Fertile women who do not agree to use highly effective contraceptive methods throughout the study period and for 120 days after the end of the study.
  • Men who have not successfully undergone vasectomy (diagnosed with azoospermia) and do not agree to use condoms/spermicides from the first dose of study treatment until 120 days after the last dose of study treatment, unless they practice abstinence.
  • Known intolerance to any study drug (or any excipient).
  • Participants who have received allogeneic tissue/solid organ transplantation.
  • Patients requiring pain medication must be on a stable treatment regimen at the start of the study.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (monthly or more frequently).
  • Uncontrolled hypertension defined as persistent blood pressure (BP) > 150 mmHg systolic or > 100 mmHg diastolic.
  • Unable to swallow tablets or capsules.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

xiongjun YE contact

+86 139 1038 0916

yexiongjun@cicams.ac.cn

xiongjun YE contact

+86 139 1038 0916

About this study

Official title: Study on the Efficacy and Safety of Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.

Read the detailed description

This study is a multicenter, prospective, phase I/II single-arm trial, aiming to enroll 37 untreated patients with advanced or metastatic ccRCC to receive vorolanib combined with cadonilimab treatment, and to perform CTC/ctDNA testing on subjects.

In the phase I dose exploration phase, a 3+3 dose escalation method is used to explore the safety of vorolanib at the standard dose combined with cadonilimab within one treatment cycle, and to determine the dose.

In the phase II trial phase, the dosage of vorolanib is determined by the optimal tolerated dose found in the phase I trial, while cadonilimab is combined for treatment.

Patients need to be evaluated for efficacy and safety after every 2 treatment cycles (within ±3 days at the end of each cycle), and continue treatment until disease progression, intolerable toxicity, or completion of the prescribed treatment cycle.

Being tested
Vorolanib, cadonilimab
Keywords
Kidney Cancer, RCC, Renal Cell Carcinoma, vorolanib Combined with Cadonilimab
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • VorolanibDrug

    Also called CM082

    stage Ⅰ：Vorolanib 200mg QD stage Ⅱ：Vorolanib RP2D QD

  • cadonilimabDrug

    Also called AK104

    stageⅠ：cadonilimab 10mg/kg Q3W stageⅡ：cadonilimab 10mg/kg Q3W

Study groups in NCT06577961
Study groupRoleWhat they receive
Experimental groupExperimentalVorolanib combined with cadonilimab
Receives: Drug: Vorolanib; Drug: cadonilimab

What is being measured

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

  1. Objective Response Rate assessed by RECIST 1.1

    ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

    Measured: 12 months

Secondary outcomes (8)

  1. Progression Free Survival assessed by the investigator

    PFS, defined as time from study drug administration to progression or death due to any cause.disease progression (PD) or death due to any reason. Imaging assessment is based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

    Measured: 24 months

  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    During the AE reporting period specified in the protocol, collect all AEs (including SAEs) and record them in the CRF form.

    Measured: 24 months

  3. Overall Survival

    OS, defined as the time from study drug administration until the date of death due to any cause.

    Measured: 24 months

  4. Disease Control Rate

    DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors.

    Measured: 12 months

  5. 12 months Progression Free Survival Rate

    The progression-free survival rate is evaluated for all enrolled patients from the start of the first treatment to 12 months.

    Measured: 12 months

  6. 12 months Overall Survival Rate

    Assess the overall survival rate for all enrolled patients from the start of the first treatment to 12 months.

    Measured: 12 months

  7. 24 months Overall Survival Rate

    Assess the overall survival rate for all enrolled patients from the start of the first treatment to 24 months.

    Measured: 24 months

  8. Health-related quality of life

    Use the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) to conduct a questionnaire survey on subjects.

    Measured: 24 months

Timeline

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

  1. First posted29 Aug 2024
  2. Study start31 Aug 2024 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (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
Model description
Vorolanib combined with cadonilimab
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577961
Sponsor's protocol ID
BD-FL-IV008
Status last verified
Aug 2024
First submitted
11 Jul 2024
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vorolanib and cadonilimab in people with Kidney Cancer and RCC, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 16 inclusion and 31 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: opening soon, as of the sponsor's last update on 29 Aug 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact xiongjun YE (+86 139 1038 0916, yexiongjun@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate assessed by RECIST 1.1 (time frame: 12 months). 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 NCT06577961.

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 29 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in