Casdatifan + Zimberelimab for Kidney Cancer

Not yet recruiting at 2 trial locations
WX
Overseen ByWenxin Xu, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to see whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC).

The names of the study drugs involved in this study are:

* Casdatifan (a type of HIF-2α inhibitor)

* Zimberelimab (a type of monoclonal antibody)

Who Is on the Research Team?

WX

Wenxin Xu, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain stages of kidney cancer (ccRCC) who are planning to have surgery. They should be relatively healthy, able to perform daily activities, and have normal blood counts and liver function tests. A confirmed diagnosis of ccRCC by biopsy is required, along with a measurable tumor.

Inclusion Criteria

My hemoglobin level is at least 10.0 g/dL.
I am 18 years old or older.
My kidney cancer can be measured and is at least 1 cm big.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Casdatifan daily for 21-day cycles, with Zimberelimab administered on Day 1 for Group B

9 weeks
3 cycles of 21 days each

Surgery

Participants undergo standard of care nephrectomy

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years
Regular visits as per protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Casdatifan
  • Zimberelimab

Trial Overview

The study is testing the safety and effectiveness of Casdatifan alone or combined with Zimberelimab in patients before they undergo kidney cancer surgery. Casdatifan inhibits HIF-2α, which may help stop cancer growth; Zimberelimab targets immune checkpoints to fight off cancer cells.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group B: Casdatifan + ZimberelimabExperimental Treatment2 Interventions
Group II: Group A: CasdatifanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Arcus Biosciences, Inc.

Industry Sponsor

Trials
44
Recruited
7,500+