Casdatifan + Cabozantinib for Kidney Cancer

Recruiting at 11 trial locations

Overseen By Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Arcus Biosciences, Inc.

Must be taking: Cabozantinib

Must not be taking: HIF-2α inhibitors

Disqualifiers: Hypertension, Prior malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or unacceptable toxicity

720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for advanced kidney cancer that has continued to grow despite previous treatment. It compares the effects of casdatifan (a new potential drug) plus cabozantinib against a placebo (a substance with no treatment effect) plus cabozantinib to determine which combination better stops cancer progression. People with advanced kidney cancer of the clear cell type who have already tried certain cancer treatments may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of casdatifan and cabozantinib is generally well-tolerated by patients with clear cell renal cell carcinoma, a type of kidney cancer. Studies indicate that nearly half of the patients responded positively to this treatment. Importantly, the side effects remain manageable. Most side effects, such as anemia (fewer red blood cells than normal), did not require a change in dosage. Overall, this suggests that the treatment is fairly safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for kidney cancer?

Researchers are excited about Casdatifan because it offers a fresh approach to treating kidney cancer. Unlike current treatments that typically focus on targeting cancer growth pathways, Casdatifan works differently by inhibiting a specific protein that plays a crucial role in cancer cell survival. This unique mechanism could potentially make it more effective in stopping cancer progression compared to existing options. Additionally, when combined with cabozantinib, a drug that already targets multiple pathways in kidney cancer, Casdatifan may enhance overall treatment effectiveness, providing hope for better outcomes.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

In this trial, participants in the experimental arm will receive a combination of casdatifan and cabozantinib. Research has shown that nearly half of the patients with advanced kidney cancer responded well to this combination. Specifically, about 4% of these patients experienced a complete disappearance of their cancer, while 42% saw a significant reduction in its size. This combination treatment has an overall response rate of 46%, indicating that nearly half of the patients had a positive outcome. These results are encouraging, particularly for those who have already tried other treatments. Additionally, the side effects were manageable, which is important for ongoing treatment. ^{1 2 4 6 7}

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 clear cell Renal Cell Carcinoma who've had their cancer progress after anti-PD-1 or anti-PD-L1 therapy. They must have good organ function, a negative pregnancy test for women of childbearing age, at least one measurable lesion not treated by radiation before, and be able to perform daily activities well (KPS score ≥ 80%).

Inclusion Criteria

My kidney cancer cannot be surgically removed and has spread.

I am mostly able to carry on with normal activities.

I am a woman who can have children and have a negative pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either casdatifan and cabozantinib or placebo and cabozantinib

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cabozantinib
• Casdatifan

Trial Overview

The study tests if Casdatifan combined with Cabozantinib improves the time patients live without their kidney cancer getting worse compared to a placebo with Cabozantinib. Participants are randomly assigned to either the drug or placebo group.

How Is the Trial Designed?

Group I: Arm A (Experimental Arm) Experimental Treatment 2 Interventions

Casdatifan and cabozantinib taken orally

Group II: Arm B (Comparator Arm) Placebo Group 2 Interventions

Placebo and cabozantinib taken orally

Who Is Running the Clinical Trial?

Arcus Biosciences, Inc.

Lead Sponsor

Trials

44

Recruited

7,500+

Citations

1.

investors.arcusbio.com

investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2025/Initial-Data-from-the-ARC-20-Study-of-Casdatifan-Plus-Cabozantinib-Showed-Nearly-Half-of-Patients-with-Metastatic-Kidney-Cancer-Had-a-Confirmed-Response/default.aspx

Initial Data from the ARC-20 Study of Casdatifan Plus ...

Nearly half of patients had a confirmed response to the casdatifan plus cabozantinib combination despite short follow-up.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4506

Combination casdatifan plus cabozantinib expansion ...

Conclusions: In previously treated patients with ccRCC, casdatifan 100 mg in combination with cabozantinib 60 mg had a manageable AE profile ...

3.

urotoday.com

urotoday.com/conference-highlights/asco-2025/asco-2025-kidney-cancer/160907-asco-2025-combination-casdatifan-plus-cabozantinib-expansion-cohort-of-phase-1-arc-20-study-in-previously-treated-patients-with-clear-cell-renal-cell-carcinoma.html

ASCO 2025: Combination Casdatifan plus Cabozantinib ...

The preliminary efficacy data for the 24 evaluable patients (2 scans required) are summarized below. At a median follow-up of 5.3 months, the confirmed ...

4.

targetedonc.com

targetedonc.com/view/casdatifan-cabozantinib-shows-efficacy-in-pretreated-ccrcc

Casdatifan/Cabozantinib Shows Efficacy in Pretreated ...

Casdatifan combined with cabozantinib demonstrated a 46% overall response rate in ccRCC patients, with 4% achieving complete responses and 42% partial responses ...

5.

onclive.com

onclive.com/view/casdatifan-plus-cabozantinib-shows-early-phase-efficacy-in-clear-cell-rcc

Casdatifan Plus Cabozantinib Shows Early-Phase Efficacy ...

The 46% confirmed ORR with a 4% CR rate and low primary progressive disease rates are impressive to think about in the context of this phase 1 ...

6.

cancernetwork.com

cancernetwork.com/view/casdatifan---cabozantinib-showed-early-efficacy-safety-in-pretreated-rcc

Casdatifan +/- Cabozantinib Showed Early Efficacy, Safety ...

Combining casdatifan plus cabozantinib (Cabometyx) led to meaningful clinical activity and was well tolerated as a therapy for patients who ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07011719

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 ...