Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria: 1. 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. • 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 stopped treatment for intolerance. 2. 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. 3. Patients must have at least one measurable site of disease per RECIST version 1.1.4. 4. ECOG performance status ≤ 1. 5. Age ≥ 18 years. 6. 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 7. 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. 8. Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan. 9. 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. 10. 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. 11. 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; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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 HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \> 14 days before starting study drug. * 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 LNK001. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of LNK001. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of LNK001. Approved methods of birth control are as follows: * 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 methods of birth control 12. Ability to understand and the willingness to sign a written informed consent document for the clinical trial. 13. Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing. Exclusion Criteria: 1. 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. 2. Major surgical procedures or serious trauma within 4 weeks