← Back to Search

Antisense Oligonucleotide

BP1001-A + Paclitaxel for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Bio-Path Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have measurable disease per RECIST criteria v1.1 and at least one 'target lesion' for assessment
Ovarian tumor patients with specified histologic epithelial cell types are eligible
Must not have
Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure
Participants with HIV infection who have specific CD4+ T-cell counts or with clinically active hepatitis B or C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 360 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The first part will see how much of the drug people can tolerate, and the second part will test the drug in combination with another cancer drug.

Who is the study for?
Adults (≥18 years) with advanced or recurrent solid tumors, such as ovarian, endometrial, fallopian tube cancer, who have no other beneficial treatments available. They must be willing to undergo biopsies and have a life expectancy >3 months. Participants need an ECOG score of 0 or 1 and adequate organ function. Women must not be pregnant and agree to birth control; men also need to use contraception.
What is being tested?
The trial is testing BP1001-A alone and combined with paclitaxel in patients with certain solid tumors. It's in phase I where they first find the safest dose for BP1001-A by itself, then see how it works together with paclitaxel regarding safety, toxicity response.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions from anticancer drugs like fatigue, nausea, allergic reactions especially related to infusion therapy (BP1001-A), bone marrow suppression leading to blood disorders or increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured and has a specific area that can be evaluated.
Select...
My ovarian cancer is of a specific cell type.
Select...
I am 18 or older with advanced cancer and no known beneficial treatment options.
Select...
My blood, liver, kidneys, nerves, and clotting functions are all working well.
Select...
I have been treated with docetaxel before.
Select...
I am fully active or can carry out light work.
Select...
I have a specific type of ovarian, peritoneal, fallopian tube, or endometrial cancer and can be treated with paclitaxel alone.
Select...
I stopped all cancer treatments, including immunotherapy, at least 4 weeks ago.
Select...
I am a woman who can have children, not pregnant, and agree to use birth control.
Select...
My endometrial cancer is of a specific cell type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no lasting side effects worse than mild from previous treatments.
Select...
I have HIV with a specific CD4+ T-cell count or active hepatitis B/C.
Select...
I have not had major surgery, dental surgery, or biopsy recently.
Select...
I have no history of brain-related health issues in the past 6 months.
Select...
I have had a bone marrow or stem cell transplant.
Select...
I have fluid buildup in my chest that causes symptoms.
Select...
I am not pregnant or breastfeeding.
Select...
I cannot or should not receive paclitaxel for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Identify Dose Limiting Toxicity (DLT) of BP1001-A
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A in combination with paclitaxel
+1 more
Secondary study objectives
Describe duration of objective response (OR)
Describe duration of overall response (OR)
Describe duration of stable disease by imaging
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BP1001-A monotherapyExperimental Treatment1 Intervention
Dose escalation of BP1001-A monotherapy
Group II: BP1001-A and PaclitaxelExperimental Treatment1 Intervention
Dose expansion of selected dose of BP1001-A with paclitaxel

Find a Location

Who is running the clinical trial?

Bio-Path Holdings, Inc.Lead Sponsor
5 Previous Clinical Trials
246 Total Patients Enrolled

Media Library

BP1001-A (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04196257 — Phase 1
Ovarian Cancer Research Study Groups: BP1001-A monotherapy, BP1001-A and Paclitaxel
Ovarian Cancer Clinical Trial 2023: BP1001-A Highlights & Side Effects. Trial Name: NCT04196257 — Phase 1
BP1001-A (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04196257 — Phase 1
~16 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top