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NCT04196257 · ClinicalTrials.gov registry record · Phase 1
BP1001-A in Patients With Advanced or Recurrent Solid Tumors
A Phase 1 study of Solid Tumor and Endometrial Cancer, sponsored by Bio-Path Holdings.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT04196257: Recruiting Phase 1 study of Solid Tumor and Endometrial Cancer, sponsored by Bio-Path Holdings.
NCT04196257 is a Phase 1 study of Solid Tumor and Endometrial Cancer that is actively recruiting participants, run by Bio-Path Holdings. The registered enrollment target is 50 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04196257, a Phase 1 study of Solid Tumor and Endometrial Cancer, is actively recruiting participants, sponsored by Bio-Path Holdings.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.
Primary Outcome
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Conditions Studied
Interventions
- DRUG BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)
- DRUG BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel
Study Locations (4)
Texas
- Mary Crowley Cancer Research - Dallas
- The University of Texas M.D. Anderson Cancer Center - Houston
Maryland
- Holy Cross Hospital - Silver Spring
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What NCT04196257 shows while recruiting
NCT04196257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (77% lower).
The record links to 6 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) is the first listed.
NCT04196257 reports a single indexed study location in Texas, Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT04196257 about?
NCT04196257 is a clinical study titled "BP1001-A in Patients With Advanced or Recurrent Solid Tumors". This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is est...
What is the current status of trial NCT04196257?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-08-19. Estimated completion is 2027-10.
What conditions does trial NCT04196257 study?
This clinical trial studies the following conditions: Solid Tumor, Endometrial Cancer, Solid Tumor, Adult, Peritoneal Cancer, Fallopian Tube Neoplasms.
What interventions are being tested in trial NCT04196257?
The interventions under investigation include: BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) (DRUG), BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04196257?
This trial is sponsored by Bio-Path Holdings, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04196257 being conducted?
This trial has 4 study locations across Maryland, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04196257's enrollment target sits among peer trials
50 122nd of 196 higher than 71 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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
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A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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