ADVANCED SOLID TUMORS: PHASE 1: OBI-888

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

Title
OBI Pharma: OBI-888-001 (Phase 1 Advanced Solid Tumors)
Study Title

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

Site Link
Malignancy
Colon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Late line
Investigational Agent
OBI-888
Drug Class
Anti-globo-H antibody
PI
Axel Grothey, MD
Sponsor
OBI Pharma
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
  • Measurable disease
  • Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
  • ECOG PS 0-1
  • Must have Globo-H overexpression as measured by central lab
  • No known active autoimmune or inflammatory disease
  • Not receiving systemic steroids of >10mg prednisone per day or equivalent
Objective
  • Primary:
    • DLT
    • MTD
  • Secondary
    • Preliminary clinical activity
    • Immunogenicity
    • PK
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Globo-H overexpression
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X