A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
casdatifan
DrugAdministered as specified in the treatment arm
Cabozantinib
DrugAdministered as specified in the treatment arm
Zimberelimab
DrugAdministered as specified in the treatment arm
Ipilimumab
DrugAdministered as specified in the treatment arm
Treatment groups
362 Participants
are divided into 15 treatment groups15
Treatment groupsSee each treatment group below.
Group A: Dose Escalation Cohort 1Experimental treatment 1 intervention
Group B: Dose Escalation Cohort 2Experimental treatment 1 intervention
Group C: Dose Escalation Cohort 3Experimental treatment 1 intervention
Group D: Dose Escalation Cohort 4Experimental treatment 1 intervention
Group E: Dose Escalation Cohort 5Experimental treatment 1 intervention
Group F: Dose Expansion Cohort 1Experimental treatment 1 intervention
Group G: Dose Expansion Cohort 2Experimental treatment 1 intervention
Group H: Dose Expansion Cohort 3Experimental treatment 1 intervention
Group I: Dose Expansion Cohort 4Experimental treatment 2 interventions
Group J: Dose Expansion Cohort 5Experimental treatment 1 intervention
Group K: Dose Expansion Cohort 6Experimental treatment 1 intervention
Group L: Dose Expansion Cohort 7Experimental treatment 2 interventions
Group M: Dose Expansion Cohort 8Experimental treatment 1 intervention
Group N: Dose Expansion Cohort 9Experimental treatment 3 interventions
Group O: Dose Expansion Cohort 10Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of participants with dose limiting toxicities (DLTs)
Time frame
Up to 4 months2
Number of participants with adverse events (AEs)
Time frame
Up to 4 monthsSecondary outcomes
1
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
Up to 4 months2
Plasma concentration of casdatifan
Time frame
Up to 4 months3
Area under the plasma concentration time curve (AUC) of casdatifan
Time frame
Up to 4 months4
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Time frame
Up to 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov