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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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year. for reporting.

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 more

Trial 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.
~8 spots leftby Apr 2025