Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Dose Escalation (Part A): Part A will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC in subjects with ccRCC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose.

Dose Expansion (Part B): Part B-1 may administer XmAb819 IV, and Part B-2 may administer XmAb819 SC.

XmAb819

Chet Bohac, MD

Lisa Finnigan

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS

Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.

Area under the plasma concentration versus time curve (AUCtau)

Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)

Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)

Duration of response (RECIST 1.1 assessment of CT/MRI imaging)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma	NCT05433142	Clear Cell Rena...	XmAb819	18 Years -	Xencor, Inc.
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma	NCT05433142	Clear Cell Rena...	XmAb819	18 Years -	Xencor, Inc.

Spots Global Cancer Trial Database for xmab819

Every month we try and update this database with for xmab819 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xmab819

Every month we try and update this database with for xmab819 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xmab819 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.