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New treatment option for Solid Tumor, Adult
Official title BP1001-A in Patients With Advanced or Recurrent Solid Tumors
ClinicalTrials.gov ID: NCT04196257
What this study is testing
What is BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)?
BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol...
- 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...
- For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial...
- Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial...
- 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)...
- 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...
- 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 \ 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...
- 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 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...
- 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 people (defined as no menses for at least 1 year)...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- (For dose expansion phase) people ineligible or unable to receive paclitaxel as treatment for their disease.
The study team makes the final eligibility decision.
Where it's taking place
- Silver Spring, Maryland, United States
- Detroit, Michigan, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Silver Spring, Maryland, United States; Detroit, Michigan, United States; Dallas, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.