Actively Recruiting
A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BP1001-A, a liposomal Grb2 antisense oligonucleotide, in adults with advanced or recurrent solid tumors. This phase I, open-label trial aims to find the safety, maximum tolerated dose, and effects of BP1001-A alone and in combination with the chemotherapy drug paclitaxel. The study focuses on patients with various solid tumors, including ovarian, fallopian tube, endometrial, and peritoneal cancers who have limited treatment options. The trial has two parts: a dose escalation phase where BP1001-A is given intravenously twice weekly for four weeks per cycle, for up to six cycles, to determine safe dosage levels; and a dose expansion phase where the selected BP1001-A dose is combined with weekly paclitaxel infusions for similar cycles. Participants in the expansion phase must have specific tumor types suitable for paclitaxel treatment. Both phases monitor how well patients tolerate the treatments and assess responses. Participants will undergo biopsies before and after treatment cycles to evaluate tumor response. Safety is closely monitored through adverse event reporting and blood tests. The study measures outcomes including dose-limiting toxicities, treatment-emergent side effects, tumor response rates by imaging and biopsy, and pharmacokinetics of BP1001-A alone and with paclitaxel. The total observation period for key outcomes extends up to 360 days, with detailed follow-up to track progression and treatment effects.
CONDITIONS
Brief 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 histologically confirmed advanced or recurrent solid tumors not suitable for standard treatments
- ECOG Performance Status of 0 or 1
- Willingness to undergo pre-treatment and post-treatment biopsies
- For dose expansion: recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube, or endometrial tumors suitable for paclitaxel treatment
- Specific histologic epithelial cell types for endometrial and ovarian tumors as detailed in the protocol
- Estimated life expectancy greater than 3 months
- Measurable disease per RECIST v1.1 with at least one target lesion amenable to biopsy
- Adequate bone marrow, liver, kidney, neurologic, and coagulation function as defined
- Previous treatment with docetaxel allowed
- Prior paclitaxel treatment allowed under certain conditions
- Free of active infections requiring antibiotics except uncomplicated UTI
- Discontinuation of hormonal or other prior cancer therapies as specified
- Negative pregnancy test for women of childbearing potential
- Agreement to use acceptable contraception during and 6 months after study
- Ability to provide informed consent
You will not qualify if you...
- Low grade serous ovarian carcinoma or mucinous ovarian carcinoma for dose expansion phase
- Recent use of strong CYP3A4 and CYP2C8 inhibitors, inducers, or substrates
- Previous bone marrow or stem cell transplant
- Use of other investigational agents
- Pregnancy or breastfeeding
- CNS disease including brain tumors, uncontrolled seizures, brain metastases, recent stroke or transient ischemic attack
- Recent serious cardiovascular events within 6 months
- Significant uncontrolled cardiac or vascular conditions
- Symptomatic pleural or pericardial effusion
- Ineligibility for MRI due to implants or claustrophobia
- Any condition making participation unsuitable as judged by investigators
- History of severe hypersensitivity to paclitaxel, docetaxel, or related products
- Unresolved toxicity from prior treatments above grade 1 except alopecia
- Substance abuse or psychological/social conditions interfering with participation
- HIV with low CD4 count or active hepatitis B or C infection
- Recent major surgery or trauma within 28 days before treatment
- Inability or unsuitability to receive paclitaxel in the dose expansion phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive BP1001-A intravenously twice weekly for 4 weeks per cycle, for up to 6 cycles. Some participants also receive weekly paclitaxel along with BP1001-A during the same treatment cycles.
Twice weekly visits for BP1001-A dosing and weekly visits for paclitaxel dosing during treatment cycles
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
M
Michael Hickey
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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