A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
- 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
- ARC-20
- 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
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-03-01
- First posted
- 2022-09-10
- Registry last updated
- 2026-07-29
- Primary completion date
- 2029-03-01
- Start date
- 2022-10-26
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Arcus Biosciences, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05536141
- ClinicalTrials.gov ID
- NCT05536141
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Number of participants with dose limiting toxicities (DLTs)
Timeframe: Up to 4 months
Number of participants with adverse events (AEs)
Timeframe: Up to 4 months
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to 4 months
Plasma concentration of casdatifan
Timeframe: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Timeframe: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Timeframe: Up to 4 months
- 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.
- 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
- Related resource (trials.arcusbio.com)
Other registry identifiers
- 2024-519142-70-00
Related records
Drugs (4)
Lead sponsors (1)
Conditions (4)
- Clear cell renal carcinoma Primary condition
- Erythrocytosis, familial, 4
- Kidney neoplasm
- Renal cell carcinoma