A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
This Phase 1 study will enroll up to approximately 550 evaluable adult participants with
refractory, advanced cancer (solid tumors).
The study will consist of a 3+3 dose escalation. Different dose levels of botensilimab, both
monotherapy and in combination with balstilimab, will be evaluated in individual cohorts
based upon dose. Each participant will remain in the cohort of the dose level and schedule
assigned at study entry. Participants can be replaced for any reason other than a
dose-limiting toxicity (DLT). Participants will receive treatment for ≤ 2 years or until
progressive disease, unacceptable toxicity, or any criterion for stopping the study drug or
withdrawal of trial occurs.
Additionally, the study is intended to further explore the safety, PK, PD, and clinical
activity in selected cancer types at dose levels (botensilimab monotherapy and combination
therapy with balstilimab) determined as potentially effective. Indications of interest
include, but are not limited to, non-small-cell lung cancer, melanoma, endometrial cancer,
ovarian cancer, angiosarcoma, colorectal cancer without liver metastases, prostate cancer,
and fibrolamellar carcinoma.
A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
PRIMARY OBJECTIVE:
I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal
men with testis cancer being treated with androgen replacement therapy.
OUTLINE: This is an observational study.
Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients
also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI.
Additionally, patients undergo blood sample collection at screening and at 12 months after
baseline MRI.
Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
PRIMARY OBJECTIVES:
I. To collect preliminary information to help design a study to look at longitudinal changes
in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine
kinase inhibitors (TKI) therapy.
SECONDARY OBJECTIVES:
I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to
undergo in vitro fertilization (IVF) for fertility preservation.
OUTLINE:
Patients undergo transvaginal ultrasound for antral follicles analysis and collection of
serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and
48 weeks.
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
PRIMARY OBJECTIVE:
I. To create an annotated biorepository with prospectively collected blood and urine samples
from men with advanced prostate cancer.
OUTLINE: This is an observational study.
Patients undergo blood and urine sample collection, complete surveys, and have their medical
records reviewed on study.
A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Phase I Design
A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will
likely be necessary to determine the MTD of temsirolimus in combination with neratinib.
There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg
administered intravenously weekly (dose level 1). Three patients will initially be enrolled
in each cohort. The Phase I portion is closed to enrollment.
Phase II Design
The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and
triple negative breast cancer—each of which has a Simon two-stage design to determine the
efficacy of temsirolimus when administered in combination with neratinib. Both pathologic
subtypes of patients will be studied separately though accrual will be simultaneous.
Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start
of therapy. As of 2/10/12, the Triple-negative cohort is closed to accrual. The HER2-
amplified cohort will continue to enroll as planned up to a total of 34 patients.
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