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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT07564232
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as Cytoxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with histologically or cytologically confirmed metastatic/advanced RCC with a clear cell component who have received at least one prior line...
- For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior...
- Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a...
- Patients must have at least one measurable site of disease per RECIST version 1.1.4.
- ECOG performance status ≤ 1.
You likely can't join if
- Participants must not have any other malignancies requiring active treatment within the past 2 years except for in situ carcinoma of any site, or...
- Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after cell...
- History of major cardiovascular diseases prior to enrollment: unstable angina, myocardial infarction, congestive heart failure (New York Heart...
- Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days...
- Patients with treated/stable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as...
- Active autoimmune diseases requiring systemic therapy (e.g., with disease-modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant...
See the full eligibility criteria
Who can join
- Patients with histologically or cytologically confirmed metastatic/advanced RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting...
- For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior lines of therapy, evidence of progression is not required if they...
- Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the...
- Patients must have at least one measurable site of disease per RECIST version 1.1.4.
- ECOG performance status ≤ 1.
- Age ≥ 18 years.
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin ≥ 8 g/dl
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ 1.5 mg/dL; for patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN
- Creatinine (CrCl) ≥ 30 mL/min using either the Cockcroft-Gault formula or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation with low molecular...
- Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan.
- For patients with a history of chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, the HBV and HCV viral loads must be undetectable.
- Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.
- The effects of LNK001 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of...
- Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the...
- Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring)
- Intrauterine device (IUD)
- Tubal Ligation or hysterectomy
- Subject/Partner post vasectomy
- Implantable or injectable contraceptives, and condoms plus spermicide
- Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable...
- Ability to understand and the willingness to sign a written informed consent document for the clinical trial.
- Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing.
What rules you out
- Participants must not have any other malignancies requiring active treatment within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or...
- Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after cell infusion (as determined by the investigator). Minor local procedures...
- History of major cardiovascular diseases prior to enrollment: unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or vascular disease (eg, aortic...
- Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, or potential need for CNS radiation within the...
- Patients with treated/stable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or...
- Active autoimmune diseases requiring systemic therapy (e.g., with disease-modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy). However, the following will be allowed:
- Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
- Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections.
- Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \> 10 mg/day or equivalent.
- Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Prior ex vivo, in vivo, autologous or allogeneic CAR T therapy.
- Prior treatment with investigational therapeutics that target CAIX or ENPP3.
- Severe infection within 4 weeks prior to enrollment (e.g. patients requiring hospitalization, severe sepsis, or severe pneumonia with respiratory failure).
- Active ongoing infection requiring oral or IV antimicrobials prior to consenting. Preventive antimicrobials are permitted
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Pregnant women are excluded from this study because LNK001 is a CAR T agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
- Patient is breastfeeding or plans to breastfeed during the study.
- Patients with persistent non-hematological grade ≥2 adverse events per NCI CTCAE v6.0 from prior systemic therapies that would confound timely detection of adverse events due to LNK001 or otherwise hinder patient...
- History or current evidence of any condition (medical [including adverse events from prior anticancer therapy, disorders secondary to tumor], surgical or psychiatric [including substance abuse]), or laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.