Phase
Condition
Neoplasms
Neuroblastoma
Treatment
PRS-344/S095012
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years on the day the consent is signed.
Patients with histologically confirmed diagnosis of unresectable, locally advancedor metastatic solid tumor for which standard treatment options are not available, nolonger effective, or not tolerated.
Patient should have a documented disease progression on prior therapy before entryinto this study.
Patients must have at least one measurable target lesion as per RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patient with no available archived material must have one or more tumor lesionsamenable to biopsy.
Adequate organ function as assessed by laboratory tests within 7 days prior topretreatment with obinutuzumab.
A female patient must use a highly effective method of birth control during studytreatment and for 120 days after last dose of PRS-344/S095012, or 18 months afterthe last obinutuzumab infusion, whichever comes the latest.
Exclusion
Exclusion Criteria:
Patients with previously treated brain metastases may participate provided they areradiologically stable, clinically asymptomatic and are off immunosuppressivetherapies for at least 4 weeks. Low dose of steroid <10 mg/day prednisone orequivalent) is allowed.
Patients who have received prior:
Small molecule inhibitors, and/or other similar investigational agent: ≤ 2weeks or 5 half-lives, whichever is shorter.
Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or othersimilar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5half-lives, whichever is shorter.
Patients who have received 4-1BB agonists in the past.
Patients who had a major surgery within 4 weeks prior to first administration ofIMP.
History of progressive multifocal leukoencephalopathy.
Active tuberculosis requiring treatment within 3 years prior to the start oftreatment or a suspicion of latent tuberculosis by the investigator.
Study Design
Study Description
Connect with a study center
Cabrini Oncology Research
Malvern, Victoria
AustraliaSite Not Available
Chris O'Brian Lifehouse
Camperdown,
AustraliaSite Not Available
The Queen Elizabeth Hospital
Woodville South,
AustraliaSite Not Available
Institute Jules Bordet
Brussels,
BelgiumSite Not Available
Universitair Ziekenhuis
Edegem,
BelgiumSite Not Available
U.Z. Gent Medical Oncology
Gent,
BelgiumSite Not Available
Hospital Vall d'Hebron
Barcelona,
SpainSite Not Available
Hospital Universitario Gregorio
Madrid,
SpainSite Not Available
START
Madrid, 28050
SpainSite Not Available
Carolina Bio Oncology
Huntersville, North Carolina 28078
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
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