Solid Tumors
Conditions
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.
Interventions
DRUGXmAb24306
Participants will receive intravenous (IV) XmAb24306.
DRUGAtezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentration of XmAb24306 | Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment |
| 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 |
| Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 | Up to approximately 4 years |
| Progression-Free Survival (PFS) as Determined by the Investigator According to 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 |
| Overall Survival (OS) | Up to approximately 4 years |
Countries
Australia, Belgium, Brazil, Canada, Italy, Netherlands, South Korea, Spain, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed