ABOUT THIS STUDY
- Advanced Solid Malignancies in Dose Escalation Parts 1 and 2:
- Histologically documented metastatic or locally advanced, incurable solid malignancy.
- At least one prior line of systemic therapy for metastatic or locally advanced disease.
- Advanced Triple Negative Breast Cancer (Dose Expansion):
- Histologically proven invasive breast carcinoma with triple-negative receptor status.
- At least 1 but no more than 2 prior lines of chemotherapy for metastatic or locally advanced disease.
- Advanced Hormone Receptor-Positive/Endocrine-Refractory Breast Cancer (Dose Expansion):
- Histologically proven invasive breast carcinoma with hormone receptor+, HER2- status.
- Only postmenopausal women are eligible. - Previously received at least 1 line of aromatase inhibitor ± cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor therapy. Prior combination therapies of AI or selective estrogen receptor degrader (SERD [fulvestrant]) ± CDK 4/6 inhibitor or AI plus everolimus will be permitted. Up to 1 prior line of systemic chemotherapy for metastatic disease is allowed.
- Advanced Metastatic Castration-Resistant Prostate Cancer (Dose Expansion):
- Histologically or cytologically confirmed prostate adenocarcinoma or poorly differentiated carcinoma of the prostate.
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If a patient is being treated with LHRH agonists, this therapy must have been initiated at least 4 weeks prior to treatment start and must be continued throughout the study.
- Patients must have received ≥1 androgen receptor (AR) signaling inhibitors and had disease progression RECIST v1.1 after no more than 1 prior chemotherapy for mCRPC.
- Advanced Platinum-Resistant Ovarian Cancer (Dose Expansion):
- Histologically or cytologically confirmed diagnosis of metastatic, advanced, or recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
- Platinum-resistant ovarian cancer defined as disease progression following a response within 180 days following the last administered dose of platinum therapy. Patients who have lack of response (SD) or disease progression while receiving the most recent platinum-based therapy are not eligible.
- Received up to 3 lines of systemic therapy for platinum-sensitive disease, with the most recent regimen platinum-containing, and no prior systemic therapy for platinum-resistant or refractory disease.
- Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
- One or more tumors measurable on radiographic imaging defined by RECIST 1.1.
- Adult patients ≥18 years of age.
- ECOG performance status (PS) score of 0 or 1.
- Life expectancy of at least 12 weeks.
- Disease-free of active second/secondary or prior malignancies for ≥2 years, with the exception of currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast.
- Acceptable liver, renal, hematologic and coagulation function.
- Hematologic malignancies or multiple myeloma.
- For the Dose Expansion cohorts the following cancers are not permitted:
- Any of the following pure histologies of ovarian cancer: germ cell, sex cord
stroma, carcinosarcoma, or sarcoma.
- Small cell or pure neuroendocrine prostate carcinoma that has not yet been
treated with at least one line of platinum-based chemotherapy (prostate
adenocarcinoma with immunohistochemical neuroendocrine differentiation but
without histological small cell that is naïve to platinum-based chemotherapy will
- Inflammatory breast cancer.
- New York Heart Association Class III or IV cardiac disease, myocardial infarction
within the past 6 months, or unstable arrhythmia.
- Cardiac function:
- Known ejection fraction of <50% by gated radionuclide study (e.g., multi-gated
- Fridericia-corrected QT interval (QTcF) >470 msec (female) or >450 msec (male),
or history of congenital long QT syndrome;
- Any ECG abnormality, including pericarditis, that in the Investigator's opinion,
would preclude safe participation in the study.
- Active, uncontrolled bacterial, viral, or fungal infections within 7 days of study
entry requiring systemic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
- Known clinically important respiratory impairment.
- History of (non-infectious) pneumonitis that required steroids or current
- History of interstitial lung disease.
- Clinically significant gastrointestinal disorders, such as perforation,
gastrointestinal bleeding, or diverticulitis.
- Known to be human immunodeficiency virus (HIV) positive or have hepatitis B surface
antigen (HBSAg) or hepatitis C antibodies (HCAb) unless hepatitis C virus (HCV) RNA is
- History of major organ transplant (i.e., heart, lungs, liver, and kidney).
- History of an allogeneic bone marrow transplant.
- History of an autologous bone marrow transplant within 90 days of study entry.
- Symptomatic central nervous system (CNS) malignancy or metastasis. Patients with
treated CNS metastases are eligible, provided their disease is radiographically
stable, asymptomatic, and they are not currently receiving corticosteroids and/or
anticonvulsants. Radiation must have been completed at least 14 days prior to study
entry. Screening of asymptomatic patients without a history of CNS metastases is not
- Serious nonmalignant disease that could compromise protocol objectives in the opinion
of the Investigator and/or the Sponsor.
- Pregnant or nursing women.
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