AB521 for Renal Cell Carcinoma
(ARC-20 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called casdatifan (also known as AB521) for individuals with advanced cancers, specifically targeting clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. Researchers aim to assess the safety of casdatifan both alone and in combination with other drugs like cabozantinib or zimberelimab. Those diagnosed with ccRCC or another solid tumor who have exhausted all other treatment options might be suitable candidates for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have had certain treatments like a HIF-2α inhibitor or cabozantinib before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that casdatifan, when used alone for patients with clear cell renal cell carcinoma (ccRCC), is generally well-tolerated. Studies have found that most patients experience only a few side effects. Additionally, casdatifan has shown promising results when combined with cabozantinib, and this combination also has a manageable safety profile, with most patients not experiencing severe side effects.
For those considering the combination of casdatifan and zimberelimab, available data suggests that casdatifan alone has been safe in past studies, and zimberelimab is generally well-tolerated in similar treatments. However, detailed safety information for this specific combination is limited.
Since this trial is in its early stages, it primarily focuses on assessing the safety of these treatments. While past data is encouraging, this study aims to confirm those findings for these new uses.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AB521 for renal cell carcinoma because it introduces casdatifan, a novel treatment that may offer new hope for patients. Unlike standard treatments like sunitinib or pembrolizumab, which primarily target angiogenesis or the immune system, casdatifan works by a potentially unique mechanism that is not yet widespread in current therapies. Additionally, its flexible administration—taken orally and sometimes in combination with other drugs like cabozantinib or zimberelimab infusion—could enhance its effectiveness and patient convenience. This new approach might lead to improved outcomes for patients who have limited options with existing therapies.
What evidence suggests that this trial's treatments could be effective for renal cell carcinoma?
Research has shown that casdatifan, which participants in this trial may receive, may help treat kidney cancer. In patients with advanced kidney cancer, casdatifan alone led to a 35% overall response rate, meaning 35% of patients saw their cancer shrink or disappear. On average, these patients went 9.7 months without their cancer worsening. In this trial, some participants will receive casdatifan combined with cabozantinib. Previous studies demonstrated that nearly half of the patients responded positively to this combination. Specifically, 4% of patients had their cancer completely disappear, and 42% saw it shrink. This combination also showed a 46% response rate in patients with clear cell renal cell carcinoma (ccRCC). These results suggest that casdatifan, both on its own and with cabozantinib, could effectively manage ccRCC.36789
Who Is on the Research Team?
Medical Director
Principal Investigator
Arcus Biosciences
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors or clear cell renal cell carcinoma (ccRCC) who have tried other treatments without success. They must have had prior anti-PD-1 therapy and a TKI, no HIF-2α-targeting therapy, at least one measurable tumor lesion, and be in good physical condition with an ECOG score of ≤ 1.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive casdatifan orally once or twice daily to determine the safety and tolerability of the drug
Dose Expansion
Participants receive casdatifan monotherapy or in combination with cabozantinib or zimberelimab to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AB521
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcus Biosciences, Inc.
Lead Sponsor