Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04084366 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by OBI Pharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT04084366: Clinical Trial Phase 1 study, sponsored by OBI Pharma.
NCT04084366 is a Phase 1 study that was terminated before completion, run by OBI Pharma. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04084366, a Phase 1 study, was terminated before completion, sponsored by OBI Pharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.
Primary Outcome
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.
Interventions
- DRUG OBI-999
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-11-25 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 1 |
Why NCT04084366 stopped before completion
NCT04084366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which OBI-999 is the first listed.
NCT04084366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04084366 about?
NCT04084366 is a clinical study titled "Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors". The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.
What is the current status of trial NCT04084366?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2019-11-25. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT04084366?
The interventions under investigation include: OBI-999 (DRUG).
Who is sponsoring clinical trial NCT04084366?
This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04084366's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI