XmAb819 for Clear Cell Renal Cell Carcinoma (ccRCC)

Phase-Based Progress Estimates

Effectiveness

Safety

Clear Cell Renal Cell Carcinoma (ccRCC)+2 More

XmAb819 - Biological

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

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

Similar Trials

Abemaciclib

ALLO-316

CTX130

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

Similar Trials

Abemaciclib

ALLO-316

CTX130

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 - 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.

References