Is NCT07748988 recruiting in Nashville, TN?

Yes, NCT07748988 is currently recruiting participants at its Nashville, TN location. This refractory clear cell renal cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Nashville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Refractory Clear Cell Renal Cell Carcinoma Clinical Trial in Nashville, TN

Q: How do I join the refractory clear cell renal cell carcinoma clinical trial in Nashville?

To join this clinical trial in Nashville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Refractory Clear Cell Renal Cell Carcinoma Study in Nashville

This is a single-institution, pilot study of oral casdatifan, a selective HIF-2α inhibitor, in patients with metastatic clear cell renal cell carcinoma refractory to prior IO- and VEGF-based therapies. This phase I trial evaluates the effects of casdatifan on certain genes linked to kidney cancer growth and tests it for the treatment of clear cell renal cell cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Casdatifan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Sponsor: Vanderbilt-Ingram Cancer Center

Who Can Participate

Inclusion Criteria

Signed and dated written informed consent.

Male or female ≥ 18 years of age on the day of signing informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Histologically confirmed metastatic clear cell renal cell carcinoma (ccRCC)

Patients must have received at least one immune oncology (IO) agent and at least one VEGF-targeted therapy (alone or in combination)

Measurable tumor burden which can be followed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST 1.1 as assessed by the local site investigator

At least one metastatic lesion that is amenable to percutaneous biopsy

Adequate organ and bone marrow function resulted ≤ 28 days prior to first dose of protocol-indicated treatment:

Absolute neutrophil count (ANC) ≥ 1500/µL.

Platelets ≥ 100,000/µL.

Hemoglobin ≥ 10.0 g/dL or ≥ 6.2 mmol/L.

Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min (as calculated by the Cockcroft-Gault Formula or calculated/measured by an alternative established institutional standard consistently applied across participants).

Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), or direct bilirubin ≤ ULN for participants with total bilirubin \> 1.5 xULN.

AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limit of normal (ULN)

Women must not be breastfeeding and further agree to not breastfeed during study treatment; and for at least 7 days after patient's final dose of casdatifan.

A woman of childbearing potential (WOCBP) - see Appendix 3 for definition of WOCBP - must have a negative serum or urine pregnancy test during screening within 28 days prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception (Appendix 3) from the time of signing consent, and until at least 7 days after her final dose of casdatifan.

Men must refrain from donating sperm for at least 7 days after patient's final dose of casdatifan.

A man able to father children (see Appendix 3 for definition) who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception (Appendix 3), from the time of signing consent, and until at least 7 days after his final dose of casdatifan.

No exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.

No active pneumonitis at screening as assessed by CT scan.

No medical history of severe chronic obstructive pulmonary disease (COPD).

If a participant has CNS metastases the participant must meet the following criteria:

Participants with previously treated brain metastases may participate provided they are clinically stable and without steroid treatment for at least 14 days prior to the first dose of study treatment. Participants with carcinomatous meningitis are excluded.

Exclusion Criteria

Prior treatment with HIF 2α inhibitors (e.g. belzutifan or related agents)

Is currently participating in or within 2 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device. • Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 2 weeks after the last dose or last exposure to the previous investigational agent or investigational device.

Known severe hypersensitivity (≥ Grade 3) to any of the excipients of casdatifan.

History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association \[NYHA\] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including TIA) within the past 6 months (24 weeks) prior to starting study treatment.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, interstitial lung disease, recent hospitalizations with unresolved symptoms, poorly controlled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.

Inability to swallow study treatment.

Contraindications to biopsy (e.g. bleeding diathesis, uncorrectable coagulopathy)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT07748988) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Refractory Clear Cell Renal Cell Carcinoma Treatment Options in Nashville, TN

If you're searching for refractory clear cell renal cell carcinoma treatment options in Nashville, TN, this clinical trial (NCT07748988) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced refractory clear cell renal cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all refractory clear cell renal cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Refractory Clear Cell Renal Cell Carcinoma Clinical Trial in Nashville, TN

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