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NCT04250155 Clinical Trial

An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Solid Tumors Clinical Trial

Official title:
A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04250155
Other study ID # GO41596
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 9, 2020
Est. completion date September 14, 2025

Study information
Verified date June 2024
Source Genentech, Inc.
Contact Reference Study ID Number: GO41596 https://forpatients.roche.com
Phone 888-662-6728
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date September 14, 2025
Est. primary completion date September 14, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key General Inclusion Criteria - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy >/= 12 weeks - Adequate hematologic and end-organ function - For participants receiving therapeutic anticoagulation: stable anticoagulant regimen - Negative serum pregnancy test for women of childbearing potential - Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Availability of representative tumor specimens Key General Exclusion Criteria - Pregnant or breastfeeding, or intending to become pregnant during the study - Significant cardiovascular disease - Current treatment with medications that prolong the QT interval - Known clinically significant liver disease - Poorly controlled Type 2 diabetes mellitus - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - History of malignancy other than disease under study within 3 years prior to screening - Active or history of autoimmune disease or immune deficiency - Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection - Positive for HIV infection - Prior allogeneic stem cell or solid organ transplantation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• XmAb24306
Participants will receive intravenous (IV) XmAb24306.
• Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
• XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.

Locations
Country Name City State
Australia Peter Mac Callum Cancer Center East Melbourne Victoria
Belgium GasthuisZusters Antwerpen Wilrijk
Brazil Hospital de Clinicas de Porto Alegre HCPA PPDS Porto Alegre PA
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Canada Sir Mortimer B Davis Jewish General Hospital Montreal Quebec
Canada Princess Margaret Hospital; Clinical Trials Pharmacy Toronto Ontario
Italy Istituto Europeo Di Oncologia Milano Lombardia
Italy Istituto Nazionale Dei Tumori; Dipartimento Chirurgia Generale - Unita' Trapianti Fegato Milano Lombardia
Italy Istituto Clinico Humanitas Rozzano (MI) Lombardia
Korea, Republic of Seoul National University Bundang Hospital; Pharmacy Seongnam-si
Korea, Republic of Asan Medical Center - PPDS Seoul
Korea, Republic of Samsung Medical Center - PPDS Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System - PPDS Seoul
Netherlands Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Amsterdam
Netherlands VU Medisch Centrum Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Spain Hospital Universitario Vall d'Hebron - PPDS Barcelona
Spain C.H. Regional Reina Sofia - PPDS Cordoba
Spain Clinica Universidad de Navarra-Madrid Madrid
Spain START Madrid-FJD, Hospital Fundacion Jimenez Diaz Madrid
Spain Clinica Universitaria de Navarra Pamplona Navarra
Spain Hospital Clinico Universitario de Valencia Valencia
United States City of Hope Comprehensive Cancer Center Duarte California
United States Virginia Cancer Specialists (Fairfax) - USOR Fairfax Virginia
United States SCRI Oncology Partners Nashville Tennessee
United States Yale University New Haven Connecticut
United States The University of Oklahoma Health Sciences Center; Peggy and Charles Stephenson Cancer Center Oklahoma City Oklahoma
United States Stanford Health Centre - Palo Alto Palo Alto California
United States UCSF Helen Diller Family CCC San Francisco California
United States University of California San Francisco Cancer Center San Francisco California
United States Honor Health Research Institute Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Italy,  Korea, Republic of,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Adverse Events Up to approximately 4 years
Secondary Serum Concentration of XmAb24306 Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment
Secondary Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to approximately 4 years
Secondary Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 Up to approximately 4 years
Secondary Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 Up to approximately 4 years
Secondary ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST) Up to approximately 4 years
Secondary DOR as Based on Radiographic Assessment by the Investigator Using iRECIST Up to approximately 4 years
Secondary PFS as Based on Radiographic Assessment by the Investigator Using iRECIST Up to approximately 4 years
Secondary Overall Survival (OS) Up to approximately 4 years
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