Clinical trialPhase 1 / Phase 2Terminated
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
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.
- Outcome
- Stopped earlyOBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients (Other)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 7 May 2018
- Expected end
- 7 April 2022
- Enrollment
- 54 participants
- Sites
- 9
- Primary outcomes
- Clinical Benefit Rate (CR, PR, SD) (%)
- Sponsor
- Industry
- Results posted
- 2024-02-22
- Last update
- 22 February 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Clinical Benefit Rate (CR, PR, SD) (%) [Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.]. Number, Percentage (95% Confidence Interval). Part A, Dose Escalation - OBI-888 5 mg/kg (n=5): 20 (0.5 to 71.6); Part A, Dose Escalation - OBI-888 10 mg/kg (n=3): 66.7 (9.4 to 99.2); Part A, Dose Escalation - OBI-888 20 mg/kg (n=6): 16.7 (0.4 to 64.1); Part B, Cohort Expansion - Cohort 1, Pancreatic (n=8): 12.5 (0.3 to 52.7); Part B, Cohort Expansion - Cohort 2, Esophageal (n=7): 14.3 (0.4 to 57.9); Part B, Cohort Expansion - Cohort 3, Gastric (n=8): 25 (3.2 to 65.1); Part B, Cohort Expansion - Cohort 4, Colorectal (n=9): 22.2 (2.8 to 60.0); Part B, Cohort Expansion - Cohort 5, Basket (n=8): 25 (3.2 to 65.1).