XmAb819 for Clear Cell Renal Cell Carcinoma (ccRCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clear Cell Renal Cell Carcinoma (ccRCC)+2 More
XmAb819 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new antibody drug to treat renal cell cancer that has returned or does not respond to other treatments. The goal is to find the safest and most effective dose.

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma (ccRCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 56 days

28 days
Incidence of dose limiting toxicities (DLTs)
Therapeutic procedure
Safety and Tolerability as assessed by incidence of DLTs
Safety and Tolerability as assessed by incidence of TEAEs, laboratory tests, clinical findings
42 days
Antitumor activity of XmAb819
Duration of response
Heart rate
Progression-free survival
56 days
Measurement of AUCtau
Measurement of Cmax
PK characterization

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Dose Escalation and Expansion
1 of 1

Experimental Treatment

95 Total Participants · 1 Treatment Group

Primary Treatment: XmAb819 · No Placebo Group · Phase 1

Dose Escalation and Expansion
Biological
Experimental Group · 1 Intervention: XmAb819 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 56 days

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
20 Previous Clinical Trials
2,096 Total Patients Enrolled
1 Trials studying Clear Cell Renal Cell Carcinoma (ccRCC)
220 Patients Enrolled for Clear Cell Renal Cell Carcinoma (ccRCC)
Zequn (Tony) Tang, MD PhDStudy DirectorXencor, Inc.

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must have measurable disease by RECIST 1.1 as assessed by the local site investigator or radiology department.
You have no symptoms or signs of cancer.
You have relapsed and refractory ccRCC and have undergone disease progression on standard-of-care therapies.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.