Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma (NCT07564232) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma
United States40 participantsStarted 2026-10-01
Plain-language summary
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.
The goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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, including at least one PD-1/PD-L1 immune checkpoint inhibitor (ICI) and one tyrosine kinase inhibitor (TKI). Patients with locally advanced disease who are eligible for curative resection are excluded.
✓. 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 study. Both overall extent of expression and staining intensity will be scored. Archival tissues that exist prior to the time of enrollment will be used for this purpose.
✓. 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:
✓. 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 weight heparin (LMWH) or direct oral anticoagulant (DOAC) is permitted if the participant is on a stable therapeutic dose for at least 2 weeks at the time of enrollment.
✓. Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan.
Exclusion criteria
✕
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
2. Ability to understand and the willingness to sign a written informed consent document for the clinical trial.
✕3. Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing.
✕. 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 post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early-stage prostate adenocarcinoma with negligible risk of metastasis or death.
✕. 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 (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.
✕. 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 aneurysm at risk of rupture) that required hospitalization within 6 months prior to consenting, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia, clinically significant pericardial effusions).
✕. 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 first 28 days from LNK001 therapy.
✕. 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:
✕. Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \> 10 mg/day or equivalent.