18 and older, any sex, with Metastatic Solid Tumors or Locally Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Benefit Rate (CR, PR, SD) (%)Primary· Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.
Group
Value
95% CI
Part A, Dose Escalation - OBI-888 5 mg/kg
20
0.5 – 71.6
Part A, Dose Escalation - OBI-888 10 mg/kg
66.7
9.4 – 99.2
Part A, Dose Escalation - OBI-888 20 mg/kg
16.7
0.4 – 64.1
Part B, Cohort Expansion - Cohort 1, Pancreatic
12.5
0.3 – 52.7
Part B, Cohort Expansion - Cohort 2, Esophageal
14.3
0.4 – 57.9
Part B, Cohort Expansion - Cohort 3, Gastric
25
3.2 – 65.1
Part B, Cohort Expansion - Cohort 4, Colorectal
22.2
2.8 – 60.0
Part B, Cohort Expansion - Cohort 5, Basket
25
3.2 – 65.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected through 12 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Metastatic Solid Tumors
Currently open trials in the same condition.
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· recruiting
NCT07159126 — A Study of DS3610a in Participants With Advanced Solid Tumor
· Phase 1
· recruiting
NCT07087197 — A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
· Phase 1
· recruiting
NCT06873789 — A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
· Phase 1, PHASE2
· active not recruiting
Other OBI Pharma, Inc trials
Trials by the same sponsor.
NCT07124117 — A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT05442060 — To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Lo
· Phase 2
· recruiting
NCT04084366 — Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· terminated
NCT03562637 — Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
· Phase 3
· active not recruiting
NCT03592264 — A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors
· Phase 1, PHASE2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OBI Pharma, Inc
Last refreshed: 22 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03573544.