NCT06264921

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

Terminated Phase 1 Last updated 25 September 2025

What this trial tests

Phase 1 trial testing NKT3447 in Solid Tumor in 23 participants. Terminated before completion.

Timeline

23 February 2024

Primary endpoint
7 April 2025

16 April 2025

Quick facts

Lead sponsor	NiKang Therapeutics, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	23 February 2024
Primary completion	7 April 2025
Estimated completion	16 April 2025
Sites	8 locations across United States

Drugs / interventions tested

• NKT3447 — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
• Metastatic Tumor — all drugs for Metastatic Tumor →

Sponsor

NiKang Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Resistance mechanisms and therapeutic strategies of CDK4 and CDK6 kinase targeting in cancer.
   Asciolla JJ, Wu X, Adamopoulos C, Gavathiotis E, et al · · 2025 · cited 15× · PMID 39885369 · DOI 10.1038/s43018-024-00893-z
2. Targeting CDK2 for cancer therapy.
   Knudsen ES, Witkiewicz AK, Sanidas I, Rubin SM. · · 2025 · cited 8× · PMID 40802510 · DOI 10.1016/j.celrep.2025.116140
3. Cyclin Dependent Kinase 2 (CDK2) Inhibitors in Oncology Clinical Trials: A Review.
   House I, Valore-Caplan M, Maris E, Falchook GS. · · 2025 · cited 5× · PMID 39811424 · DOI 10.36401/jipo-24-22
4. Reduced Levels of miR-145-3p Drive Cell Cycle Progression in Advanced High-Grade Serous Ovarian Cancer.
   González-Cantó E, Monteiro M, Aghababyan C, Ferrero-Micó A, et al · · 2024 · cited 4× · PMID 39594652 · DOI 10.3390/cells13221904
5. Targeting CDK2 and other novel cell cycle targets for breast cancer therapy.
   Chen MK, Luo L, Massoumi N, Keyomarsi K. · · 2025 · cited 2× · PMID 40692275 · DOI 10.1080/14728222.2025.2537412
6. From CDK4/6 to CDK2 and KAT: Evolving therapeutic approaches in HR+/HER2- breast cancer.
   Stachyra P, Hernando Meliá C, López-Guerrero JA, Gavilá Gregori J, et al · · 2026 · PMID 42061029 · DOI 10.1016/j.breast.2026.104791
7. Emerging Protein Targets in Triple-Negative Breast Cancer: Beyond Conventional Therapy
   Previtali A, Guardamagna I, Calandra S, Shakarami M, et al · · 2026
8. Novel Cell Cycle Inhibitors Decrease Primary and Metastatic Breast Cancer Growth In Vivo.
   Maqbool MS, Zhang Y, Strittmatter K, Gvozdenovic A, et al · · 2026 · PMID 41681937 · DOI 10.3390/cancers18030466