Clinical trial NCT04250155: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Serum Concentration of XmAb24306
timeFrame: Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment
measure: Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
timeFrame: Up to approximately 4 years
measure: Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
timeFrame: Up to approximately 4 years
measure: ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)
timeFrame: Up to approximately 4 years
measure: DOR as Based on Radiographic Assessment by the Investigator Using iRECIST
timeFrame: Up to approximately 4 years
measure: PFS as Based on Radiographic Assessment by the Investigator Using iRECIST
timeFrame: Up to approximately 4 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Centre - Palo Alto
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Ann Arbor
country: United States
facility: City of Hope Comprehensive Cancer Center
state: Michigan
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Melbourne
country: Australia
facility: Parkville Cancer Clinical Trial Unit (PCCTU)
state: Victoria
city: Wilrijk
country: Belgium
facility: GasthuisZusters Antwerpen
state: Antwerp
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre HCPA PPDS
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital
state: Quebec
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Córdoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Cordoba
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Madrid
city: Madrid
country: Spain
facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: