A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer
Primary:
To identify the MTD and dose for Part B by: Evaluating the safety profile of escalating doses and different schedules of NXP800. Identification of DLTs.
Secondary:
To evaluate the PK profile of NXP800.
Exploratory:
To describe the antitumor activity of NXP800 in various tumor types.
To describe the effect of NXP800 on tumor markers (where applicable).
To describe the treatment effect of NXP800 on pharmacodynamic markers.
- Rutgers Cancer Institute of New Jersey
Part A Inclusion Criteria:
- Provide written informed consent.
- 18 years old or older.
- Life expectancy of at least 12 weeks.
- Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive
solid tumors for whom there is no authorized or effective therapy available, or for
whom such therapies are considered inappropriate by the Investigator (in Part B,
subjects with specific cancer types will be enrolled; Specific criteria will be
introduced in a protocol amendment).
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Part A Exclusion Criteria:
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or
investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first
dose of NXP800. Subjects can continue to receive bisphosphonates due to metastatic
bone disease or GnRH agonists if they have prostate cancer.
- Ongoing toxic manifestations of previous treatments > Grade 2.
- Subjects with treated brain metastases are eligible if there is no evidence of
progression for at least 28 days after central nervous system (CNS) directed
treatment, as ascertained by clinical examination and brain imaging (magnetic
resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
- Female subjects who can become pregnant (or are already pregnant or lactating).
- Male subjects with partners of childbearing potential (unless they agree to take
measures not to father children by using a barrier method of contraception (condom
plus spermicide) or to sexual abstinence).
Part B Inclusion Criteria:
- Provide written informed consent.
- 18 years old or older.
- Subjects with the following ARID1a mutated, ovarian/fallopian tube/primary peritoneal
cancer histologies (ARID1a mutation status determined by a DNA-based Next Generation
Sequencing test):
- Clear cell ovarian carcinoma (≥ 50% clear cell carcinoma with no serous
differentiation)
- Endometrioid ovarian carcinoma
- Subjects must have disease progression within 6 months (182 days) from completion of
platinum-based therapy (6 months should be calculated from the date of the last
administered dose of platinum therapy to the date of radiographic imaging showing
progression)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Version 1.1.
- Subjects with a BRCA mutation must have received prior treatment with a PARP
inhibitor.
- Subjects must have received at least 1 but not more than 3 prior systemic lines of
anticancer therapy, including at least 1 line of therapy containing bevacizumab.
- Adjuvant + neoadjuvant are considered one line of therapy
- Maintenance therapy (i.e., bevacizumab, PARP inhibitors) will be considered as
part of the preceeding line of therapy and are not counted independently.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects must have a sufficient archival Formalin-Fixed Paraffin-Embedded (FFPE)
tissue specimen, or be willing to consent to a fresh tissue biopsy during the study.
Part B Exclusion Criteria:
- Subjects with disease that did not respond to, or has progressed during or within 4
weeks of the last dose of first-line platinum containing chemotherapy.
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or
investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first
dose of NXP800.
- Ongoing toxic manifestations of previous treatments > Grade 2, with the exception of
alopecia.
- Subjects with treated brain metastases are eligible if there is no evidence of
progression for at least 12 weeks while off corticosteroids after central nervous
system (CNS) directed treatment, as ascertained by clinical examination and brain
imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the
Screening period.
- Female subjects who can become pregnant (or are already pregnant or lactating).
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.