Casdatifan for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental drug called casdatifan for individuals with kidney cancer that has spread and did not respond to previous treatments. The main goal is to determine how casdatifan affects certain genes in the cancer cells. To achieve this, the study will examine cancer samples and blood at various stages of treatment. Suitable candidates have kidney cancer that has spread, have tried other treatments without success, and have at least one cancer spot that can be biopsied. As an Early Phase 1 trial, this research aims to understand how casdatifan works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that casdatifan is likely to be safe for humans?
Studies have shown that casdatifan is generally well-tolerated by people with kidney cancer. In earlier research, patients taking 100 mg of casdatifan daily experienced manageable side effects, indicating that while some side effects may occur, they are not severe. Researchers have tested casdatifan both alone and with other treatments, like cabozantinib, and it has shown promising safety results in both scenarios.
Patients have responded well to casdatifan, with 25% to 35% of those with clear cell renal cell carcinoma, a type of kidney cancer, showing positive responses. These findings suggest that casdatifan is not only effective but also safe at the tested doses. Although this trial is in its early stages, previous studies support its safety for further testing.12345Why do researchers think this study treatment might be promising?
Casdatifan is unique because it offers a new approach to treating kidney cancer by being an oral medication that can be taken once daily with or without food. Unlike standard treatments for kidney cancer, which often involve targeted therapies like tyrosine kinase inhibitors or immunotherapies, casdatifan introduces a different mechanism that researchers are exploring to see if it can improve outcomes. Researchers are excited about casdatifan because its oral administration could provide a more convenient option for patients, potentially leading to better adherence and quality of life during treatment.
What evidence suggests that casdatifan might be an effective treatment for kidney cancer?
Research has shown that casdatifan holds promise for treating metastatic clear cell renal cell carcinoma, a type of kidney cancer. Previous studies found that about 25% to 35% of patients who took casdatifan experienced tumor shrinkage or halted growth. This translates to roughly one in three patients benefiting from the treatment. In some instances, the benefits lasted over a year, with patients averaging 15.1 months before cancer progression. Overall, casdatifan has demonstrated encouraging results and lasting effects in patients who have previously tried other treatments. Participants in this trial will receive casdatifan to further evaluate its effectiveness and safety.13467
Who Is on the Research Team?
Brian Rini
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with metastatic clear cell kidney cancer that has not responded to previous immunotherapy and VEGF-targeted treatments. Participants must be able to take oral medication and provide tumor biopsies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral casdatifan at a fixed dose of 100 mg once daily until disease progression or intolerable toxicity
Biopsy and Blood Sample Collection
Collection of fresh tumor tissue and peripheral blood at baseline, during treatment, and at end of treatment for exploratory biomarker analyses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- casdatifan
Trial Overview
The study tests casdatifan, an oral drug targeting HIF-2α, in people with advanced kidney cancer. Researchers will monitor changes in gene activity from tumor samples before, during, and after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Casdatifan 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Arcus Biosciences, Inc.
Industry Sponsor
Citations
1.
urologytimes.com
urologytimes.com/view/casdatifan-is-linked-with-promising-safety-efficacy-in-clear-cell-rccCasdatifan is linked with promising safety, efficacy in clear ...
Casdatifan showed promising clinical activity in clear cell RCC, with response rates between 25% and 33% across dosage cohorts.
Casdatifan shows durable response linked to HIF-2α ...
The confirmed objective response rates (ORRs) were 35% (95% confidence intervals (CI) = 19–55%; 100 mg QD) and 31% (95% CI = 23–40%; total); ...
Activity and biomarker analyses with casdatifan (cas), a ...
ORR was 35% Cas monotherapy showed encouraging clinical activity and durable responses across cohorts.
Arcus Presents New Data for its HIF-2a Inhibitor Casdatifan ...
Median progression-free survival (mPFS) was 15.1 months, and the confirmed overall response rate (cORR) increased to 45% for the 100mg QD ...
5.
cancernetwork.com
cancernetwork.com/view/casdatifan-monotherapy-achieves-clinical-activity-in-late-line-kidney-cancerCasdatifan Monotherapy Achieves Clinical Activity in Late- ...
Casdatifan, administered at 100 mg once daily, achieved a confirmed ORR of 35% in patients with pretreated metastatic kidney cancer.
Initial Data from the ARC-20 Study of Casdatifan Plus ...
If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, ...
NCT07011719 | Study of Casdatifan and Cabozantinib ...
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with ...
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