A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors

Inclusion Criteria:

Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the investigator.

Dose Escalation:

Ovarian cancer
Endometrial cancer
Gastric cancer or gastroesophageal junction cancer
Small cell lung cancer
Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen receptor, progesterone receptor negative)
Estrogen receptor/progesterone-receptor + human epidermal growth factor receptor 2 negative (HER2-) breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
Other solid tumors with CCNE1 amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next generation sequencing by local liquid or tissue biopsy.

Dose Expansion:

a. Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with cyclin E amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next-generation sequencing by local liquid or tissue biopsy.

Measurable disease per the RECIST v1.1
An Eastern Cooperative Oncology Group performance status of 0 to 1
Able to swallow oral medications.

Exclusion Criteria:

Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
History of another malignancy with exceptions
Visceral crisis, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis
Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
Clinically active interstitial lung disease
History of uveitis, retinopathy or other clinically significant retinal disease
Has known human immunodeficiency virus (HIV), active hepatitis B or C infection
Prior CDK2 inhibitor, WEE1 inhibitor, or protein kinase membrane associated tyrosine/threonine 1 inhibitor.
Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447