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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 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.

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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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2022-08-19
Est. Completion 2027-10
Phase Phase 1

Sponsor

Bio-Path Holdings

5 total trials

What the Registry Record Tells You About NCT04196257

The ClinicalTrials.gov registry entry for NCT04196257 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (77% lower). The listed sponsor is Bio-Path Holdings, which has 5 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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