The goal of the Dose Escalation phase of the study is to evaluate the safety,
tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD)
and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with
advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to
evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor
activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at
the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2
dose (RP2D).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06264921.
This is a Phase 1/1b, first-in-human, open-label, multicenter study of NKT3447 in adults
with advanced/ metastatic solid tumors. The study consists of 2 parts, a Dose Escalation
phase and a Dose Expansion phase. Eligible patients must have confirmed
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:
1. Ovarian cancer
2. Endometrial cancer
3. Gastric cancer or gastroesophageal junction cancer
4. Small cell lung cancer
5. Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen
receptor, progesterone receptor negative)
6. Estrogen receptor/progesterone-receptor positive (ER+/PR+), 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)
7. Other solid tumors with CCNE1 amplification as determined by 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.
The Dose Escalation phase will evaluate the safety, tolerability, and pharmacokinetics
(PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose
for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors.
The Dose Expansion phase will evaluate the safety, tolerability, pharmacokinetics (PK),
and the preliminary antitumor activity of NKT3447 in adult subjects with CCNE1 amplified
ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary
recommended RP2D.
Lead OrganizationNiKang Therapeutics, Inc.
