Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma Osteosarcoma and Other Solid Tumor Cancers

  • STATUS
    Recruiting
  • End date
    Feb 3, 2022
  • participants needed
    30
  • sponsor
    Y-mAbs Therapeutics
Updated on 3 June 2021
ct scan
platelet count
cancer
cyclophosphamide
methotrexate
vincristine
measurable disease
MRI
bone marrow procedure
etoposide
doxorubicin
catecholamines
metastasis
neutrophil count
positron emission tomography
refractory neuroblastoma
cancer chemotherapy
solid tumor
iobenguane
sarcoma
medulloblastoma
desmoplastic
fibrosarcoma
liposarcoma
leiomyosarcoma
mycn protein
monoclonal antibody 3f8
hu3f8
refractory osteosarcoma
humanized 3f8 bispecific antibody

Summary

The purpose of this study is to test the safety of a study drug called humanized 3F8 bispecific antibody (Hu3F8-BsAb).

Details
Condition Osteosarcoma, Neuroblastoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, Other Solid Tumor Cancers, bone sarcoma, neuroblastomas
Treatment Blood draw, Humanized 3F8 Bispecific Antibody
Clinical Study IdentifierNCT03860207
SponsorY-mAbs Therapeutics
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase I
Patients must have either (1) a diagnosis of NB as defined by international criteria,i.e.,histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels, or (2) high grade osteosarcoma verified by histopathology (confirmed by the MSKCC Department of Pathology), or (3) other GD2-expressing solid tumor
For tumors other than NB and osteosarcoma, only tumors known to be GD2 positive are eligible: melanoma, desmoplastic small round cell tumors, retinoblastoma, medulloblastoma, and soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma. Patients with medulloblastoma are eligible only if they have metastatic disease outside the CNS (e.g. in the bone marrow)
NB patients must have chemorefractory (e.g. refractory to standard induction chemotherapy including cyclophosphamide, vincristine, cisplatin, etoposide) or relapsed high-risk (HR) neuroblastoma. HR NB is defined as MYCN-amplified stage 3/4/4S of any age, or MYCNnonamplified stage 4 in patients > 18 months of age at diagnosis
Osteosarcoma patients must have relapsed or refractory osteosarcoma after receiving standard systemic chemotherapy (e.g. combination methotrexate, doxorubicin, and cisplatin [MAP])
For non-NB and non-osteosarcoma tumors known to be GD2(+), patients must have relapsed or refractory disease that is resistant to standard therapy
Phase II
Group 1
NB patients must have chemo refractory or relapsed HR NB. HR NB is defined as MYCNamplified stage 3/4/4S of any age, or MYCN-nonamplified stage 4 in patients > 18 months of age at diagnosis
The diagnosis of NB must be defined by international criteria i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels
Group 2
Patients must have a diagnosis of high grade osteosarcoma defined by histopathology (confirmed by the MSKCC Department of Pathology)
Patients must have relapsed or refractory osteosarcoma after receiving standard systemic chemotherapy (e.g. combination methotrexate, doxorubicin, and cisplatin [MAP])
All criteria below are common to both phase I and phase II
Disease status
For NB patients, patients must have measurable or evaluable disease (e.g. abnormal findings in computed tomography (CT), magnetic resonance imaging (MRI), metaiodobenzylguanidine (MIBG) scan, or positron emission tomography (PET)) OR morphologic evidence of disease in bone marrow
For osteosarcoma or other GD2(+) solid tumor patients, patients must have measurable disease
Other criteria
Patients must be 1 year of age and < 18 years of age
Patients with prior exposure to anti-GD2 antibodies must have a negative HAHA antibody titer
Adequate hematopoietic function defined as
Absolute neutrophil count 500/ul
Absolute lymphocyte count 500/ul
Platelet count 25,000/ul
Negative serum pregnancy test in women of child-bearing potential
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Signed informed consent indicating awareness of the investigational nature of this program

Exclusion Criteria

Patients who are in complete remission
Existing severe major organ dysfunction. i.e. renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity Grade 3 except for hearing loss, alopecia, anorexia, nausea, hyperbilirubinemia or hypomagnesemia from TPN, which may be Grade 3
Hematologic and active CNS malignancies including CNS metastasis
Active life-threatening infection
Pregnant women or women who are breast-feeding
Inability to comply with protocol requirements
History of autoimmune disease with potential CNS involvement or a current autoimmune disease
Chemotherapy or immunotherapy within three weeks prior to study enrollment. T-cell based immunotherapies (e.g. CAR-modified T cells, checkpoint inhibitors) should have been completed >6 weeks prior to treatment with hu3F8-BsAb
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