Your session is about to expire
← Back to Search
Monoclonal Antibodies
OBI-888 for Metastatic Tumor
Phase 1 & 2
Waitlist Available
Led By Apostolia Tsimberidou, MD, PHD
Research Sponsored by OBI Pharma, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat cancer.
Eligible Conditions
- Metastatic Tumor
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate (CR, PR, SD) (%)
Secondary outcome measures
Measurement of preliminary clinical activity profile (objective response rate [ORR], clinical benefit rate [CBR], duration of response (DOR), and PFS) of OBI-888 in patients.
Measurement of the OBI-888 immunogenicity (anti-drug antibodies [ADAs]) in patients.
PK - clearance (Cl)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: OBI-888 Expansion PhaseExperimental Treatment2 Interventions
Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
Group II: OBI-888 Escalation PhaseExperimental Treatment2 Interventions
Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).
Find a Location
Who is running the clinical trial?
OBI Pharma, IncLead Sponsor
7 Previous Clinical Trials
1,324 Total Patients Enrolled
Apostolia Tsimberidou, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
68 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Share this study with friends
Copy Link
Messenger