Actively Recruiting
BP1001-A in Patients With Advanced or Recurrent Solid Tumors
Led by Bio-Path Holdings, Inc. · Updated on 2025-03-07
50
Participants Needed
4
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BP1001-A in Patients With Advanced or Recurrent Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with advanced or recurrent solid tumors not suitable for standard treatments
- ECOG Performance Status of 0 or 1
- Willingness to undergo pre-treatment biopsies and post-treatment biopsies if completing one treatment cycle
- For dose expansion, having recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube, or endometrial tumors suitable for single-agent paclitaxel
- Specific histologic subtypes of endometrial and ovarian tumors as detailed in the protocol
- Estimated life expectancy greater than 3 months
- Measurable disease per RECIST v1.1 criteria with at least one lesion suitable for biopsy
- Adequate bone marrow, liver, kidney, neurologic, and blood coagulation function
- Previous treatment with docetaxel allowed
- For dose expansion, prior paclitaxel allowed if no progression or relapse within 6 months post-therapy
- Free from active infections requiring antibiotics except uncomplicated urinary tract infection
- Discontinuation of hormonal or other prior cancer therapies as specified
- Negative pregnancy test for women of childbearing potential and agreement to use birth control during and 6 months after study
- Male participants must agree to use contraception
- Ability and willingness to provide informed consent
You will not qualify if you...
- Low-grade serous or mucinous ovarian carcinoma for dose expansion phase
- Recent use (within 2 weeks) of strong CYP3A4 and CYP2C8 inhibitors, inducers, or substrates for dose expansion
- Prior bone marrow or stem cell transplant
- Current use of other investigational agents
- Pregnant or breastfeeding women
- CNS disease including brain tumors, uncontrolled seizures, brain metastases, or recent stroke
- Recent serious cardiovascular events within 6 months
- Unstable or significant heart conditions or abnormal ECG
- Symptomatic pleural or pericardial effusion
- Inability to undergo MRI
- Any condition making participation unsafe or unsuitable
- History of severe hypersensitivity to paclitaxel or docetaxel
- Unresolved severe toxicity from prior treatments except hair loss
- Substance abuse or psychological/social conditions affecting participation
- HIV with low CD4 count or active hepatitis B or C
- Recent major surgery or trauma within 28 days prior to treatment
- Ineligibility or inability to receive paclitaxel for dose expansion phase
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
3
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
4
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Brian Forbes
CONTACT
M
Michael Hickey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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