Solid Tumor, AdultPhase 1NCT04196257
BP1001-A in Patients With Advanced or Recurrent Solid Tumors
A Phase 1 study testing BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) and BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel in people with Solid Tumor, Adult and Carcinoma, Ovarian Epithelial, run by Bio-Path Holdings, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
- What is being tested?
- BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) and BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Aug 2022to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol treatments known to confer clinical benefit.
- ECOG Performance Status Score of 0 or 1.
- Participants must be willing to undergo pre-treatment biopsies. Participants who complete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatment biopsies will be offered to participants who do not complete 1 cycle of treatment.
- For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and must be participants for whom single agent paclitaxel would be considered a reasonable treatment option.
- Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell, transitional cell carcinoma, and mesonephric carcinoma.
- Ovarian tumor patients with the following histologic epithelial cell types are eligible: High-grade serous carcinoma, endometrioid carcinoma, clear cell carcinoma, squamous carcinoma, transitional cell (Brenner) carcinoma, mixed epithelial-stromal carcinoma, undifferentiated or other epithelial carcinoma.
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- Uterine carcinosarcoma and other sarcomas of the uterus are not eligible.
- Estimated life expectancy > 3 months in the Investigator's opinion.
- All participants must have measurable disease per RECIST criteria v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >/= 20 mm when measured by conventional techniques, including plain x-ray, CT, and MRI, or >/= 10 mm when measured by spiral CT. Measurable disease lesions must be amenable to pre- and post-treatment biopsy.
- Participants must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Participants must have adequate:
- Bone marrow function: HgB >/= 9 g/dL, WBC >/= 3,000/mcL, ANC >/= 1,500/mcL, PLT >/= 100,000/mcL
- Hepatic function: Total bilirubin within normal institutional limits, AST and ALT < 2.5 X institutional ULN
- Renal function: Serum creatinine < 1.5 x ULN or eGFR > 60 mL/min according to Cockcroft-Gault formula
- Neurologic function: Neuropathy (sensory and motor) </= CTCAE Grade 1
- Blood coagulation parameters: PT such that INR is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a PTT < 1.2 times control
- Participants previously treated with docetaxel (regardless of response) are eligible for this trial.
- Participants in the dose expansion phase who previously received paclitaxel for primary or recurrent disease are eligible if they did not progress on therapy or relapse within 6 months of completing therapy. Participants with persistent disease at the completion of primary therapy with paclitaxel are not eligible.
- Participants should be free of active infection requiring antibiotics, with the exception of uncomplicated UTI.
- Any hormonal therapy directed at the malignant tumor must be discontinued at least two weeks prior to BP1001-A treatment. Continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy for prostate cancer (e.g., leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian or breast cancer are not exclusionary.
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to first dose of BP1001-A (6 weeks for nitrosoureas or mitomycin C).
- Female participants of childbearing potential must have a negative urine pregnancy test performed within 24 hours prior to the start of study treatment. Post-menopausal subjects (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
- Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of treatment.
- Male participants must agree to use an acceptable method of contraception for the duration of the study.
- Participants must be willing and able to provide written informed consent.
Who cannot join
- For the dose expansion phase, participants must not have low grade serous ovarian carcinoma or mucinous ovarian carcinoma.
- For the dose expansion phase, participants must wait at least two weeks after receiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8 before investigational drug administration.
- Participants who had previous bone marrow or hematopoietic stem cell transplant.
- Participants may not be receiving any other investigational agents.
- Female participants who are pregnant or breast-feeding.
- History or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months of registration on this study.
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- Within the past 6 months, participant has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident, or transient ischemic attack.
- Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, NYHA class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia, or clinically significant baseline ECG abnormality (e.g., QTcF >470 msec).
- Active pleural effusion or pleural or pericardial effusion with symptoms. Pleural or pericardial effusion that has received treatment and resolved according to the Investigator, is acceptable.
- Participants who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not MR compatible, such as ferromagnetic implants or pacers or with a known history of allergic reaction to gadolinium contrast agents.
- Any condition which, in the Investigator's opinion, makes the subject unsuitable for trial participation.
- A prior history of ≥ Grade 3 hypersensitivity to paclitaxel or docetaxel or with products mixed in Cremephor EL or Tween 80®.
- Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia.
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Participants with HIV infection who have CD4+ T-cell counts < 350 cells/mcL or with clinically active hepatitis B or C infection.
- Participants who have a major surgical procedure, open biopsy, dental extractions, or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to registration.
- (For dose expansion phase) Subjects ineligible or unable to receive paclitaxel as treatment for their disease.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Joshua Matson, 214-545-3933, jomatson@marycrowley.org
Minal Barve, M.D.
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Entela Rama, 313-576-9447, ramae@karmanos.org
Victoria LaBush, CCRP, 313-576-8411, labushv@karmanos.org
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Shannon Westin, M.D., M.P.H., 713-794-4314
Shannon Westin, MD
- Recruiting
Holy Cross Hospital
Silver Spring, Maryland, 20910
Sujana Lalagari, 571-226-0078, sujana.lalagari@holycrosshealth.org
James Barter, MD, jfbmd1@aol.com
About this study
Official title: A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) 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 established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.
- Conditions
- Solid Tumor, Adult, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Endometrial Cancer, Peritoneal Cancer, Solid Tumor
- Being tested
- BP1001-A (Liposomal Grb2 Antisense Oligonucleotide), BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)Drug
Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BP1001-A monotherapy | Experimental | Dose escalation of BP1001-A monotherapy Receives: Drug: BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) |
| BP1001-A and Paclitaxel | Experimental | Dose expansion of selected dose of BP1001-A with paclitaxel Receives: Drug: BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Dose Limiting Toxicity (DLT) of BP1001-A
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify maximum tolerated dose (MTD) of BP1001-A
Identify MTD based on dose limiting toxicities (DLT) of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A
Identify and grade TEAE of escalating doses of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A in combination with paclitaxel
Identify and grade TEAE of BP1001-A in combination with paclitaxel using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Secondary outcomes (15)
Frequency and severity of Adverse Events (AEs) of BP1001-A monotherapy and in combination with paclitaxel
Determine frequency and grade of AEs per NCI CTCAE criteria
Measured: 30 days
Determine objective response rate (ORR) by biopsy
Determine ORR by tumor biopsy using Response Criteria in Solid Tumors (RECIST)
Measured: 180 days
Determine objective response rate (ORR) by imaging
Determine ORR by MRI or CT imaging using Response Criteria in Solid Tumors (RECIST)
Measured: 180 days
Describe duration of overall response (OR)
Describe duration of OR using tumor biopsy per RECIST
Measured: 180 days
Describe duration of objective response (OR)
Describe duration of OR using MRI or CT imaging per RECIST
Measured: 180 days
Describe duration of stable disease by imaging
Describe duration of stable using MRI or CT imaging per RECIST
Measured: 180 days
Describe duration of stable disease by tumor biopsy
Describe duration of stable disease using tumor biopsy per RECIST
Measured: 180 days
Describe progression-free survival (PFS) per RECIST by biopsy
Describe PFS using tumor biopsy per RECIST
Measured: 360 days
Describe progression-free survival (PFS) per RECIST by imaging
Describe PFS using MRI or CT imaging per RECIST
Measured: 360 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Cmax)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using maximum plasma drug concentration (Cmax)
Measured: 30 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Tmax)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using time of maximal observed concentration (Tmax)
Measured: 30 days
Determine plasma pharmacokinetics (PK)of BP1001-A monotherapy and in combination with paclitaxel (AUC)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using Area Under the Curve (AUC)
Measured: 30 days
Determine plasma pharmacokinetics of BP1001-A monotherapy and in combination with paclitaxel (CL)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using clearance rate (CL)
Measured: 30 days
Determine half-life plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (t1/2)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using mean terminal elimination half life (t1/2)
Measured: 30 days
Frequency and severity of AEs of BP1001-A in combination with paclitaxel
Determine frequency and grade of AEs of BP1001-A in combination with paclitaxel per NCI CTCAE criteria
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start19 Aug 2022
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Path Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196257
- Sponsor's protocol ID
- BP1001-A-101-GynOnc
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT04196257
- Acronym / sponsor ID
- BP1001-A-101-GynOnc
- Conditions
- Solid Tumor, Adult, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Endometrial Cancer, Peritoneal Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bio-Path Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP1001-A monotherapy | Experimental | Drug: BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)Dose escalation of BP1001-A monotherapy |
| BP1001-A and Paclitaxel | Experimental | Drug: BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxelDose expansion of selected dose of BP1001-A with paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol treatments known to confer clinical benefit.
- ECOG Performance Status Score of 0 or 1.
- Participants must be willing to undergo pre-treatment biopsies. Participants who complete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatment biopsies will be offered to participants who do not complete 1 cycle of treatment.
- For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and must be participants for whom single agent paclitaxel would be considered a reasonable treatment option.
- Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell, transitional cell carcinoma, and mesonephric carcinoma.
Key exclusion criteria (17 listed)
- For the dose expansion phase, participants must not have low grade serous ovarian carcinoma or mucinous ovarian carcinoma.
- For the dose expansion phase, participants must wait at least two weeks after receiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8 before investigational drug administration.
- Participants who had previous bone marrow or hematopoietic stem cell transplant.
- Participants may not be receiving any other investigational agents.
- Female participants who are pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles. | Drug | BP1001-A monotherapy |
| BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxelDose 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. | Drug | BP1001-A and Paclitaxel |
Primary outcome
Identify Dose Limiting Toxicity (DLT) of BP1001-A
Time frame: 30 days
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Identify maximum tolerated dose (MTD) of BP1001-A
Time frame: 30 days
Identify MTD based on dose limiting toxicities (DLT) of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A
Time frame: 30 days
Identify and grade TEAE of escalating doses of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A in combination with paclitaxel
Time frame: 30 days
Identify and grade TEAE of BP1001-A in combination with paclitaxel using non-hematologic and hematologic measures per NCI CTCAE criteria
15 secondary outcomes
Frequency and severity of Adverse Events (AEs) of BP1001-A monotherapy and in combination with paclitaxel
Time frame: 30 days
Determine objective response rate (ORR) by biopsy
Time frame: 180 days
Determine objective response rate (ORR) by imaging
Time frame: 180 days
Describe duration of overall response (OR)
Time frame: 180 days
Describe duration of objective response (OR)
Time frame: 180 days
Describe duration of stable disease by imaging
Time frame: 180 days
Describe duration of stable disease by tumor biopsy
Time frame: 180 days
Describe progression-free survival (PFS) per RECIST by biopsy
Time frame: 360 days
Describe progression-free survival (PFS) per RECIST by imaging
Time frame: 360 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Cmax)
Time frame: 30 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Tmax)
Time frame: 30 days
Determine plasma pharmacokinetics (PK)of BP1001-A monotherapy and in combination with paclitaxel (AUC)
Time frame: 30 days
Determine plasma pharmacokinetics of BP1001-A monotherapy and in combination with paclitaxel (CL)
Time frame: 30 days
Determine half-life plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (t1/2)
Time frame: 30 days
Frequency and severity of AEs of BP1001-A in combination with paclitaxel
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) and BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel in people with Solid Tumor, Adult and Carcinoma, Ovarian Epithelial, run by Bio-Path Holdings, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Forbes (832-742-1365, bforbes@biopathholdings.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Dose Limiting Toxicity (DLT) of BP1001-A (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.