Health Trials

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

ConditionsClear Cell Renal Cell CarcinomaSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorArcus Biosciences, Inc.

About this trial

The purpose of this study is to evaluate the safety and tolerability of:

* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Eligibility criteria

Qualifiers

Must have at least one measurable lesion per RECIST guidance

Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1

Participants may have any pathologically confirmed solid tumor type where no other treatment options are available

Creatinine clearance ≥ 40 mL/min

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • casdatifan
  • Cabozantinib
  • Zimberelimab
  • Ipilimumab

Treatment groups

362 Participants
are divided into 15 treatment groups

15

Treatment groups

See each treatment group below.

Locations

25
Australia
Research Site Camperdown Australia
Research Site Melbourne Australia
Research Site Sydney Australia
South Korea
Research Site Seoul South Korea

Sponsors and collaborators

Arcus Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov