Receive monthly emails about the latest oncology research and technology, new patient services, resources and more!

Please select an option below to help us tailor your newsletter to best suit your content interests!

No thanks
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
_



Assessment Frequency Link
Path
Globo-H overexpression
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X