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New drug combo targets Hard-to-Treat kidney cancer

NCT ID NCT05536141

Disease control Sponsor: Arcus Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This early-stage study tests a new drug called casdatifan (AB521) alone or combined with other cancer drugs in people with advanced clear cell kidney cancer or other solid tumors. The main goals are to check safety and find the right dose. About 362 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
casdatifan (AB521), cabozantinib, zimberelimab, ipilimumab
What this could lead to
If successful, this could point toward a new treatment option for advanced kidney cancer and other solid tumors.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Must have at least one measurable lesion per RECIST guidance * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 * Disease-specific criteria for dose escalation: * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available * Creatinine clearance ≥ 40 mL/min Disease-specific criteria for dose-expansion: * Histologically confirmed ccRCC * Creatinine clearance ≥ 40 mL/min Key Exclusion Criteria: * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product * Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous * History of trauma or major surgery within 28 days prior to the first dose of investigational product * For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

erythrocytosis, familial, 4 kidney cancer neoplasm nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clear cell renal cell carcinoma Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Research Site

    RECRUITING

    San Diego, California, 92093, United States

  • Research Site

    RECRUITING

    Santa Monica, California, 90404, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33136, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

  • Research Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Research Site

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • Research Site

    RECRUITING

    New York, New York, 10029, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37240, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Research Site

    NOT_YET_RECRUITING

    Camperdown, Australia

  • Research Site

    RECRUITING

    Melbourne, Australia

  • Research Site

    RECRUITING

    Sydney, Australia

  • Research Site

    RECRUITING

    Seoul, South Korea

  • Research Site

    RECRUITING

    Barcelona, Spain

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