A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors

Status: Terminated
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

‣ Measurable disease per the RECIST v1.1

⁃ An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

⁃ Able to swallow oral medications.

∙ Dose Escalation(Part 1):

⁃ Ovarian cancer

⁃ Endometrial cancer

⁃ Gastric cancer or gastroesophageal junction cancer

⁃ Small cell lung cancer (SCLC)

⁃ Triple-negative breast cancer (human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], progesterone receptor negative)

⁃ ER/progesterone-receptor positive, HER2 negative 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 NGS by local liquid or tissue biopsy.

∙ Dose Expansion (Part 2):

∙ 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 CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.

• Measurable disease per the RECIST v1.1

• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Able to swallow oral medications.

Locations
United States
California
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco
Colorado
Sarah Cannon Research Institute at HealthONE
Denver
Florida
AdventHealth Cancer Institute
Celebration
Georgia
Augusta University Georgia Cancer Center
Augusta
Kentucky
Norton Cancer Institute - Broadway
Louisville
Ohio
The Gabrail Pharmacology Phase 1 Research Center
Canton
Texas
Texas Oncology-Austin Midtown NEXT Oncology
Austin
Utah
START Mountain Region
West Valley City
Time Frame
Start Date: 2024-02-23
Completion Date: 2025-04-16
Participants
Target number of participants: 23
Treatments
Experimental: Dose Escalation
Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3447 at increasing dosage levels to determine the MTD and/or preliminary RDEs.
Experimental: Dose Expansion
Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D.
Sponsors
Leads: NiKang Therapeutics, Inc.

This content was sourced from clinicaltrials.gov