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ADVANCED SOLID TUMORS: LATE LINE: GLOBO-H POSITIVE: OBI-999-001

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

Title
OBI Pharma OBI-999-001 Advaned solid tumors GLOBO-H positive
Study Title

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

Site Link
Malignancy
Pancreatic, Esophageal, Gastric, Colorectal, Breast, Lung, Prostate, Melanoma, Head and Neck, Sarcoma, Bladder, Renal Cell, Ovarian, Endometrial, Cervical
Stage
Disease Setting
Metastat
Line Of Therapy
Late line
Investigational Agent
OBI-999
Drug Class
Globo H targeting agent
PI
Dan Vaena, MD
Sponsor
OBI Pharma
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed patients with advanced solid tumors
  • Must have documented Globo H score of at least 100 from a qualified laboratory IHC assay
  • Must have been treated with established standard-f-care therapy or physicians have determined that such established therapy is not sufficiently efficacious or patients have declined to received standard-of-care therapy
  • ECOG PS 0-1
  • Measurable disease
  • Adequate organ function
  • No known untreated CNS mets
  • No significant clinical cardiac abnormality
Objective
  • Primary
    • DLT
    • MTD
  • Secondary
    • ORR
    • CBR
    • DOR
    • PFS
    • Immunogenicity
    • PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Any solid tumor
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X