RecruitingPhase 1NCT04196257

BP1001-A in Patients With Advanced or Recurrent Solid Tumors

A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors

Sponsor

Bio-Path Holdings, Inc.

Enrollment

50 participants

Start Date

Aug 19, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Solid Tumor Solid Tumor, Adult Peritoneal Cancer Fallopian Tube Neoplasms Carcinoma, Ovarian Epithelial

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called BP1001-A in patients with advanced solid tumors, including ovarian, fallopian tube, peritoneal, or endometrial cancers, to determine safe doses and whether the drug has anti-cancer activity. **You may be eligible if...** - You are 18 or older with a confirmed advanced or recurrent solid tumor - You are no longer a candidate for standard treatments - You have a good general health status (ECOG 0 or 1) - You are willing to provide tumor biopsy samples before and after treatment - For the expansion phase: you have recurrent ovarian, peritoneal, fallopian tube, or endometrial cancer **You may NOT be eligible if...** - You have a performance status that is too poor for treatment - You are not willing to provide tumor biopsies - Your cancer has not been histologically or cytologically confirmed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBP1001-A (Liposomal Grb2 Antisense Oligonucleotide)

Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.

DRUGBP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel

Dose expansion of BP1001-A IV twice weekly (Maximum tolerated dose or Maximum admistered dose) plus paclitaxel IV weekly for 4 weeks (28-day cycle) for 6 cycles.