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Cohort 3: Dose 3 for Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clear Cell Renal Cell Carcinoma+1 MoreAB521 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multicenter, open-label, Phase 1 study to evaluate the safety, pharmacokinetic (PK), preliminary clinical activity, pharmacodynamic (PD), and biomarkers of AB521 as monotherapy for advanced solid tumor malignancies (dose escalation) and clear cell renal cell carcinoma (ccRCC) (dose expansion).

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma
  • Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 4 months

Up to 4 months
Area under the plasma concentration time curve (AUC) of AB521
Maximum Observed Plasma Concentration (Cmax) of AB521
Number of participants reporting serious adverse events (SAEs) and non-SAEs
Number of participants with incidence of dose limiting toxicities (DLTs)
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Plasma concentration of AB521

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Belzutifan
1
XmAb819
1
Aldesleukin

Trial Design

4 Treatment Groups

Cohort 3: Dose 3
1 of 4
Cohort 4: Dose 4
1 of 4
Cohort 2: Dose 2
1 of 4
Cohort 1: Dose 1
1 of 4

Experimental Treatment

86 Total Participants · 4 Treatment Groups

Primary Treatment: Cohort 3: Dose 3 · No Placebo Group · Phase 1

Cohort 3: Dose 3
Drug
Experimental Group · 1 Intervention: AB521 · Intervention Types: Drug
Cohort 4: Dose 4
Drug
Experimental Group · 1 Intervention: AB521 · Intervention Types: Drug
Cohort 2: Dose 2
Drug
Experimental Group · 1 Intervention: AB521 · Intervention Types: Drug
Cohort 1: Dose 1
Drug
Experimental Group · 1 Intervention: AB521 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
31 Previous Clinical Trials
5,596 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,638 Previous Clinical Trials
7,941,911 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants may have any pathologically confirmed solid tumor type where no other treatment options are available.
You have at least one measurable lesion per RECIST guidance.
References

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