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Casdatifan for Healthy Subjects

MD
Overseen ByMedical Director
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Arcus Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the body processes a new drug called casdatifan. The study compares the effects of taking one 100 mg tablet versus four 25 mg tablets and examines whether eating affects the drug's efficacy when taken as four 25 mg tablets. It is open to healthy non-smokers who weigh at least 45 kg and can easily swallow multiple tablets. Participants should not have a history of asthma, serious food allergies, or certain neurological issues. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 has shown that casdatifan is generally safe and well-tolerated. Earlier studies found that both healthy individuals and patients with conditions like cancer experienced similar safety outcomes. No unexpected safety issues emerged, and the treatment was manageable at various doses. Some studies noted that casdatifan was well-tolerated, even in patients with kidney cancer. However, a smaller number of participants experienced serious side effects, such as anemia (low red blood cell count) and hypoxia (low oxygen levels). Overall, the treatment appears fairly safe for most people based on the available data.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about casdatifan because it offers a potentially new approach to managing conditions that involve inflammation and immune response. Unlike current treatments that primarily use steroids or NSAIDs to control inflammation, casdatifan is designed to work by targeting specific pathways in the immune system, potentially offering more precise control with fewer side effects. This trial explores different dosages and conditions, such as fasting and fed states, to understand how the body absorbs the drug, which could lead to more effective treatment regimens.

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

Research has shown that casdatifan may be promising for treating kidney cancer. Studies found that patients lived over 15 months on average without their cancer worsening. The treatment worked for 25% to 45% of patients, depending on the dose. This suggests that casdatifan could help slow cancer progression and improve patient health. While the main focus has been on kidney cancer, these results suggest casdatifan might also be useful for treating other types of cancer.

In this trial, participants will receive different dosages of casdatifan to evaluate its effects in healthy subjects.13467

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Arcus Biosciences

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not smoke or use nicotine, have a BMI between 18 and 32, weigh at least 45 kg, are free of significant medical issues, can swallow multiple tablets, and have good vein access.

Inclusion Criteria

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
* BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
* Has adequate peripheral venous access.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single-dose treatments to evaluate pharmacokinetics under different conditions

3 periods
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Casdatifan

Trial Overview

The study compares how the body processes one casdatifan 100 mg tablet versus four 25 mg tablets when taken without food. It also looks at how eating affects the absorption of four 25 mg casdatifan tablets.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Treatment CExperimental Treatment1 Intervention
Group II: Treatment BExperimental Treatment1 Intervention
Group III: Treatment AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arcus Biosciences, Inc.

Lead Sponsor

Trials
44
Recruited
7,500+

Taiho Pharmaceutical Co., Ltd.

Industry Sponsor

Trials
67
Recruited
18,600+

Masayuki Kobayashi

Taiho Pharmaceutical Co., Ltd.

Chief Executive Officer since 2012

Background in political and law studies

Harold Keer

Taiho Pharmaceutical Co., Ltd.

Chief Medical Officer since 2024

MD

Citations

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 ...

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 ...

Casdatifan 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.

Pharmacokinetics, pharmacodynamics and safety of ... - PMC

Casdatifan, after single and multiple dosing in healthy participants, was safe and tolerable. Linear PK was associated with a mean maximum ...

Casdatifan Monotherapy Shows Early Efficacy Signals and ...

Casdatifan demonstrated clinical activity in previously treated ccRCC patients, with response rates between 25% and 33% across dosage regimens.

Press Release Details - Investors & Media - Arcus Biosciences

No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses.

Casdatifan + Cabozantinib for Kidney Cancer

Overall, this suggests that the treatment is fairly safe for most patients. Show more.