Casdatifan for the Treatment of Refractory Metastatic Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorVanderbilt-Ingram Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
casdatifan
DrugCasdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CasdatifanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population.
A serial biopsy design, incorporating biopsies at baseline, on-treatment, and disease progression, enables longitudinal evaluation of the HIF-2α transcriptional program and characterization of adaptive or resistance-associated gene expression changes emerging during therapy.
Time frame
1 year (From baseline to on-treatment biopsy)Secondary outcomes
1
To assess changes in global tumor gene expression following casdatifan treatment.
Differential expression of genome-wide transcripts between baseline and on-treatment biopsies.
Time frame
1 year (From baseline to on-treatment biopsy)2
To identify differences in baseline and on-treatment HIF-mediated gene expression between objective responders and non-responders.
Comparison of RNA expression profiles stratified by best overall response per RECIST v1.1
Time frame
1 year (From baseline to on-treatment biopsy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt-Ingram Cancer Center
Lead sponsor
Arcus Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov