Overview

BP1001-A in Patients With Advanced or Recurrent Solid Tumors

Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bio-Path Holdings, Inc.
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

1. All participants, ≥ 18 years of age, with histologic proof of advanced or recurrent
solid tumors, who are not candidates for known regimens or protocol treatments of
higher efficacy or priority

2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1

3. 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

4. For the dose expansion phase, participants must have recurrent or persistent
epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor

5. 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. Uterine carcinosarcoma and other sarcomas of the
uterus are not eligible.

6. Estimated life expectancy > 3 months in the investigator's opinion

7. All participants must have measurable disease. 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 ≥ 10 mm when measured by conventional
techniques, including palpitation, 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

8. 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

9. Participants must have adequate:

Bone marrow function: Hemoglobin (HgB) > 9 g/dL, White blood cells (WBC) >3,000/mcL,
Absolute neutrophil count (ANC) >1,500/mcL, Platelets (PLT) >100,000/mcL Hepatic
function: Total bilirubin within normal institutional limits, aspartate
aminotransaminase (AST) and alanine aminotransaminase (ALT) < 2.5 X institutional
upper limits of normal (ULN) Renal function: Serum creatinine < 1.5 x ULN or estimated
glomerular filtration rate (eGFR) > 60 mL/min according to Cockcroft-Gault formula
Neurologic function: Neuropathy (sensory and motor) < CTCAE Grade 1 Blood coagulation
parameters: Prothrombin time (PT) such that international normalized ratio (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 partial thromboplastin
time (PTT) < 1.2 times control.

10. Participants previously treated with docetaxel (regardless of response) are eligible
for this trial

11. 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

12. Participants should be free of active infection requiring antibiotics, with the
exception of uncomplicated urinary tract infection (UTI)

13. 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 (i.e. for prostate cancer (e.g.
leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian or breast cancer
are not exclusionary

14. 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)

15. Female participants of childbearing potential must have a negative urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin
(hCG) 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

16. 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

17. Male participants must agree to use an acceptable method of contraception for the
duration of the study

18. Participants must be willing and able to provide written informed consent

Exclusion Criteria:

1. For the dose expansion phase, participants must not have low grade serous ovarian
carcinoma or mucinous ovarian carcinoma

2. Participants who had previous bone marrow or hematopoietic stem cell transplant

3. Participants who have undergone prior radiation to abdomen and pelvis (if
myelosuppression is likely to occur)

4. Participants may not be receiving any other investigational agents

5. Female participants who are pregnant or breast-feeding

6. Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for
curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial
bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades
lamina propria)]

7. 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

8. 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

9. 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, New York Heart
Association (NYHA) class III or IV congestive heart failure, uncontrolled and
sustained hypertension, clinically significant cardiac dysrhythmia or clinically
significant baseline electrocardiogram (ECG) abnormality (e.g., QTcF >470 msec)

10. Active pleural or pericardial effusion of any grade

11. 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

12. Any condition which, in the investigator's opinion, makes the subject unsuitable for
trial participation

13. A prior history of ≥grade 3 hypersensitivity to paclitaxel or docetaxel or with
products mixed in Cremephor EL or Tween 80®

14. Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy or
procedure, excluding alopecia

15. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

16. Known history of human immunodeficiency virus (HIV) infection or clinically active
hepatitis B or C infection

17. 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