BP1001-A in Patients With Advanced or Recurrent Solid Tumors

Inclusion Criteria:

1. All participants, ≥ 18 years of age, with histologic evidence of advanced orrecurrent solid tumors, who are not candidates for regimens or protocol treatmentsknown to confer clinical benefit.

2. ECOG Performance Status Score of 0 or 1.

3. Participants must be willing to undergo pre-treatment biopsies. Participants whocomplete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatmentbiopsies will be offered to participants who do not complete 1 cycle of treatment.

4. For the dose expansion phase, participants must have recurrent or persistentepithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and mustbe participants for whom single agent paclitaxel would be considered a reasonabletreatment option.

5. Endometrial cancer patients with the following histologic epithelial cell types areeligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiatedcarcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma nototherwise specified, mucinous adenocarcinoma, squamous cell, transitional cellcarcinoma, and mesonephric carcinoma. Ovarian tumor patients with the following histologic epithelial cell types areeligible: High-grade serous carcinoma, endometrioid carcinoma, clear cell carcinoma,squamous carcinoma, transitional cell (Brenner) carcinoma, mixed epithelial-stromalcarcinoma, undifferentiated or other epithelial 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 per RECIST criteria v1.1. Measurabledisease is defined as at least one lesion that can be accurately measured in atleast one dimension (longest dimension to be recorded). Each lesion must be >/= 20mm 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 topre- and post-treatment biopsy.

8. Participants must have at least one "target lesion" to be used to assess response onthis protocol as defined by RECIST v1.1. Tumors within a previously irradiated fieldwill be designated as "non-target" lesions unless progression is documented or abiopsy is obtained to confirm persistence at least 90 days following completion ofradiation therapy.

9. Participants must have adequate:

10. Bone marrow function: HgB >/= 9 g/dL, WBC >/= 3,000/mcL, ANC >/= 1,500/mcL, PLT >/= 100,000/mcL

11. Hepatic function: Total bilirubin within normal institutional limits, AST andALT < 2.5 X institutional ULN

12. Renal function: Serum creatinine < 1.5 x ULN or eGFR > 60 mL/min according toCockcroft-Gault formula

13. Neurologic function: Neuropathy (sensory and motor) </= CTCAE Grade 1

14. 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 therapeuticwarfarin or low molecular weight heparin) and a PTT < 1.2 times control

15. Participants previously treated with docetaxel (regardless of response) are eligiblefor this trial.

16. Participants in the dose expansion phase who previously received paclitaxel forprimary or recurrent disease are eligible if they did not progress on therapy orrelapse within 6 months of completing therapy. Participants with persistent diseaseat the completion of primary therapy with paclitaxel are not eligible.

17. Participants should be free of active infection requiring antibiotics, with theexception of uncomplicated UTI.

18. Any hormonal therapy directed at the malignant tumor must be discontinued at leasttwo weeks prior to BP1001-A treatment. Continuation of hormone replacement therapyis permitted; stable regimens of hormonal therapy for prostate cancer (e.g.,leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian or breastcancer are not exclusionary.

19. Any other prior therapy directed at the malignant tumor, including immunologicagents, must be discontinued at least four weeks prior to first dose of BP1001-A (6weeks for nitrosoureas or mitomycin C).

20. Female participants of childbearing potential must have a negative urine pregnancytest performed within 24 hours prior to the start of study treatment.Post-menopausal subjects (defined as no menses for at least 1 year) and surgicallysterilized women are not required to undergo a pregnancy test.

21. Female participants of childbearing potential must agree to use an acceptable methodof birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragmwith spermicide, condom with spermicide or abstinence) for the duration of the studyand for at least 6 months after the last dose of treatment.

22. Male participants must agree to use an acceptable method of contraception for theduration of the study.

23. 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 ovariancarcinoma or mucinous ovarian carcinoma.

2. For the dose expansion phase, participants must wait at least two weeks afterreceiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8before investigational drug administration.

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

4. Participants may not be receiving any other investigational agents.

5. Female participants who are pregnant or breast-feeding.

6. History or evidence upon physical examination of CNS disease, including primarybrain tumor, seizures not controlled with standard medical therapy, any brainmetastases, or history of cerebrovascular accident (CVA, stroke), transient ischemicattack or subarachnoid hemorrhage within 6 months of registration on this study.

7. Within the past 6 months, participant has had any of the following: myocardialinfarction, unstable angina pectoris, coronary/peripheral artery bypass graft,cerebrovascular accident, or transient ischemic attack.

8. Presence of concurrent conditions that, in the opinion of the Investigator and/orMedical Monitor, may compromise the participant's ability to tolerate studytreatment or interfere with any aspect of study conduct or interpretation ofresults. This includes, but is not limited to, unstable or uncontrolled angina, NYHAclass III or IV congestive heart failure, uncontrolled and sustained hypertension,clinically significant cardiac dysrhythmia, or clinically significant baseline ECGabnormality (e.g., QTcF >470 msec).

9. Active pleural effusion or pleural or pericardial effusion with symptoms. Pleural orpericardial effusion that has received treatment and resolved according to theInvestigator, is acceptable.

10. Participants who are ineligible to undergo an MRI scan for reasons such asclaustrophobia or the presence of implanted devices or metallic foreign bodies thatare not MR compatible, such as ferromagnetic implants or pacers or with a knownhistory of allergic reaction to gadolinium contrast agents.

11. Any condition which, in the Investigator's opinion, makes the subject unsuitable fortrial participation.

12. A prior history of ≥ Grade 3 hypersensitivity to paclitaxel or docetaxel or withproducts mixed in Cremephor EL or Tween 80®.

13. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy orprocedure, excluding alopecia.

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

15. Participants with HIV infection who have CD4+ T-cell counts < 350 cells/mcL or withclinically active hepatitis B or C infection.

16. Participants who have a major surgical procedure, open biopsy, dental extractions,or other dental surgery/procedure that results in an open wound, or significanttraumatic 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 priorto registration.

17. (For dose expansion phase) Subjects ineligible or unable to receive paclitaxel astreatment for their disease.