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

Purpose

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 in participants with ccRCC in the dose expansion stage

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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 - 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation Cohort 1
Participants will receive casdatifan orally once daily
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Escalation Cohort 2
Participants will receive casdatifan orally once daily
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Escalation Cohort 3
Participants will receive casdatifan orally twice daily
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Escalation Cohort 4
Participants will receive casdatifan orally once daily
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Escalation Cohort 5
Participants will receive casdatifan orally once daily
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 1
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 2
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 3
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 4
Participants will receive casdatifan orally with with cabozantinib orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
  • Drug: Cabozantinib
    Administered as specified in the treatment arm
Experimental
Dose Expansion Cohort 5
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 6
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
Experimental
Dose Expansion Cohort 7
Participants will receive casdatifan orally with zimberelimab infusion
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
  • Drug: Zimberelimab
    Administered as specified in the treatment arm
Experimental
Dose Expansion Cohort 8
Participants will receive casdatifan orally
  • Drug: casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37240

More Details

Status
Recruiting
Sponsor
Arcus Biosciences, Inc.

Study Contact

Medical Director
+1-510-462-3330
ClinicalTrialInquiry@arcusbio.com