BP1001-A in Patients With Advanced or Recurrent Solid Tumors
A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors
1 other identifier
interventional
50
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2022
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedStudy Start
First participant enrolled
August 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 7, 2025
March 1, 2025
4.9 years
December 10, 2019
March 6, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Identify Dose Limiting Toxicity (DLT) of BP1001-A
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
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
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
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
30 days
Secondary Outcomes (15)
Frequency and severity of Adverse Events (AEs) of BP1001-A monotherapy and in combination with paclitaxel
30 days
Determine objective response rate (ORR) by biopsy
180 days
Determine objective response rate (ORR) by imaging
180 days
Describe duration of overall response (OR)
180 days
Describe duration of objective response (OR)
180 days
- +10 more secondary outcomes
Study Arms (2)
BP1001-A monotherapy
EXPERIMENTALDose escalation of BP1001-A monotherapy
BP1001-A and Paclitaxel
EXPERIMENTALDose expansion of selected dose of BP1001-A with paclitaxel
Interventions
Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +9 more criteria
You may not qualify 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 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 12, 2019
Study Start
August 19, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 7, 2025
Record last verified: 2025-03