NP-G2-044 as Monotherapy and Combination Therapy in Patients

Recruiting

Female

Phase 1

5 participants needed

1 Location

Brief description of study

NP-G2-044 Monotherapy Primary Objectives The primary objectives for patients receiving NP-G2-044 monotherapy are the following: 1) to identify the recommended Phase 2 dose (RP2D) of continuously dosed NP-G2-044 monotherapy (Mono-RP2D) and characterize its safety; and 2) to assess preliminary signals of NP-G2-044 anti-tumor efficacy when administered as continuously dosed monotherapy.

Detailed description of study

The Treatment Period will be made up of 28-day cycles. During Cycle 1, you will be asked to return to the study clinic on the first day of treatment (Day 1) and then on days 8, 15, and 22 for study tests and procedures. Beginning with Cycle 2, and for every cycle afterwards, you will be asked to return to the study clinic on treatment day (Day 1) and on Day15. Treatment visits may last only a few hours or may last most of the day, depending on the tests and procedures required for that visit. The study team will tell you more about how long each visit is expected to take.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Advanced or Metastatic Solid Tumor Malignancies including ovarian, endometrial/uterine, fallopian tube, cervical, vulvar, and vaginal cancers
Gender: Female

Have a histopathologically confirmed advanced or metastatic solid tumor malignancy that is

either treatment-refractory or otherwise ineligible for treatment with standard of care

agents/regimens.

For monotherapy expansion cohort (after the Mono-RP2D has been identified), patients must

have:

a. Gynecologic malignancies including ovarian, endometrial/uterine, fallopian tube, cervical,

vulvar, and vaginal cancers; or

b. Epidermal growth factor receptor (EGFR)-high (2+ or 3+ staining per DAKO criteria or

genomic sequencing data showing 3 or more copies of the EGFR gene) triple-negative

breast cancer (TNBC).

Updated on 01 Aug 2024. Study ID: 851126

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