AB521 for Renal Cell Carcinoma
(ARC-20 Trial)

Recruiting at 35 trial locations

Overseen ByMedical Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Arcus Biosciences, Inc.

Must not be taking: HIF-2α inhibitors, Cabozantinib

Disqualifiers: Cardiac, Respiratory, Psychiatric, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called AB521 to see if it is safe for people with advanced cancers, including a type of kidney cancer called clear cell renal cell carcinoma. In some parts of the study, AB521 will be used alone, and in others, it will be combined with another drug called cabozantinib, which stops cancer cells from growing.

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.

What makes the drug AB521 (casdatifan) unique for treating renal cell carcinoma?

AB521 (casdatifan) is unique because it targets the HIF-2α pathway, which is involved in tumor growth and resistance to other treatments. This mechanism is different from many existing therapies that focus on inhibiting blood vessel growth or modulating the immune system.¹ ² ³ ⁴ ⁵

Research Team

Medical Director

Principal Investigator

Arcus Biosciences

Eligibility Criteria

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

I am fully active or have some restrictions but can still care for myself.

I have kidney cancer, treated with specific drugs but not HIF-2α inhibitors.

I have a solid tumor cancer with no other treatment options left.

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Exclusion Criteria

I have not received any live vaccines in the last 4 weeks.

I have not had major surgery or serious injury in the last 28 days.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive casdatifan orally once or twice daily to determine the safety and tolerability of the drug

8-12 weeks

Dose Expansion

Participants receive casdatifan monotherapy or in combination with cabozantinib or zimberelimab to further evaluate safety and efficacy

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

AB521

Trial OverviewThe study tests the safety and tolerability of AB521 as a solo treatment for patients with various advanced solid tumors including ccRCC. It aims to find out how well participants handle this new drug and what effects it has on their cancer.

Participant Groups

13Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 8Experimental Treatment1 Intervention