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
- Registration Number
- NCT04250155
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a Dose Escalation XmAb24306 Participants will receive XmAb24306 until study treatment discontinuation or study termination. Phase 1a Dose Expansion XmAb24306 Participants will receive XmAb24306 until study treatment discontinuation or study termination. Phase 1b Dose Escalation Atezolizumab Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. Phase 1b Dose Escalation XmAb24306 Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. Phase 1b Dose Expansion Atezolizumab Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. Phase 1b Dose Expansion XmAb24306 Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 Up to approximately 4 years Serum Concentration of XmAb24306 Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 Up to approximately 4 years Overall Survival (OS) Up to approximately 4 years 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 ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST) Up to approximately 4 years DOR as Based on Radiographic Assessment by the Investigator Using iRECIST Up to approximately 4 years PFS as Based on Radiographic Assessment by the Investigator Using iRECIST Up to approximately 4 years
Trial Locations
- Locations (28)
GasthuisZusters Antwerpen
🇧🇪Wilrijk, Antwerp, Belgium
Istituto Clinico Humanitas
🇮🇹Rozzano, Lombardia, Italy
Severance Hospital Yonsei University Health System - PPDS
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Stanford Health Centre - Palo Alto
🇺🇸Palo Alto, California, United States
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
City of Hope Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Parkville Cancer Clinical Trial Unit (PCCTU)
🇦🇺Melbourne, Victoria, Australia
Hospital de Clinicas de Porto Alegre HCPA PPDS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷São Paulo, Brazil
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Noord-Holland, Netherlands
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
C.H. Regional Reina Sofia - PPDS
🇪🇸Córdoba, Cordoba, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Clinica Universidad de Navarra-Madrid
🇪🇸Madrid, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain