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

Phase
Recruitment status
Participants
Lead sponsor
Arcus Biosciences, Inc.
Start date
Number of sites

Summary
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.
Acronym
Short title
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Official title
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Arcus Biosciences, Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Number of participants with dose limiting toxicities (DLTs)

    Timeframe: Up to 4 months

  2. Number of participants with adverse events (AEs)

    Timeframe: Up to 4 months

  1. Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Timeframe: Up to 4 months

  2. Plasma concentration of casdatifan

    Timeframe: Up to 4 months

  3. Area under the plasma concentration time curve (AUC) of casdatifan

    Timeframe: Up to 4 months

  4. Maximum Observed Plasma Concentration (Cmax) of casdatifan

    Timeframe: Up to 4 months

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

Sources for eligibility

  • Research SiteBirmingham, United StatesRecruiting
  • Research SiteSan Diego, United StatesRecruiting
  • Research SiteSanta Monica, United StatesRecruiting
  • Research SiteMiami, United StatesRecruiting
  • Research SiteAtlanta, United StatesRecruiting
  • Research SiteLouisville, United StatesRecruiting
  • Research SiteNew Orleans, United StatesRecruiting
  • Research SiteBaltimore, United StatesRecruiting
  • Research SiteBoston, United StatesRecruiting
  • Research SiteDetroit, United StatesRecruiting
  • Research SiteDetroit, United StatesRecruiting
  • Research SiteOmaha, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteCleveland, United StatesRecruiting
  • Research SiteCleveland, United StatesRecruiting
  • Research SitePittsburgh, United StatesRecruiting
  • Research SiteNashville, United StatesRecruiting
  • Research SiteNashville, United StatesRecruiting
  • Research SiteSan Antonio, United StatesRecruiting
  • Research SiteCamperdown, AustraliaNot yet recruiting
  • Research SiteMelbourne, AustraliaRecruiting
  • Research SiteSydney, AustraliaRecruiting
  • Research SiteSeoul, South KoreaRecruiting
  • Research SiteBarcelona, SpainRecruiting
Sources for sites

Other registry identifiers

  • 2024-519142-70-00
Sources for references

Related records

Drugs (4)

Lead sponsors (1)

Conditions (4)

Targets (4)