NCT05023486

NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies

Active, enrolled Phase 1, PHASE2 Last updated 14 April 2026

What this trial tests

Phase 1, PHASE2 trial testing NP-G2-044 Monotherapy in Advanced or Metastatic Solid Tumor Malignancies in 121 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 December 2021

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	Novita Pharmaceuticals, Inc.
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	121
Start date	7 December 2021
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	18 locations across United States

Drugs / interventions tested

• NP-G2-044 Monotherapy — full drug profile →
• Anti-PD-1 Therapy — full drug profile →
• NP-G2-044 Combination therapy — full drug profile →

Conditions studied

• Advanced or Metastatic Solid Tumor Malignancies — all drugs for Advanced or Metastatic Solid Tumor Malignancies →

Sponsor

Novita Pharmaceuticals, Inc. — full company profile →

Who can join

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

Sponsor's own description

Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy, PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in combination with anti-PD-1 therapy.

Publications & conference data

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

1. Fascin-1 in Cancer Cell Metastasis: Old Target-New Insights.
   Sarantelli E, Mourkakis A, Zacharia LC, Stylianou A, et al · · 2023 · cited 18× · PMID 37511011 · DOI 10.3390/ijms241411253
2. Targeting FSCN1 with an oral small-molecule inhibitor for treating ocular neovascularization.
   Bai W, Ren JS, Xia M, Zhao Y, et al · · 2023 · cited 13× · PMID 37596693 · DOI 10.1186/s12967-023-04225-0
3. Fascin-1: Updated biological functions and therapeutic implications in cancer biology.
   Li CH, Chan MH, Liang SM, Chang YC, et al · · 2022 · cited 12× · PMID 37082587 · DOI 10.1016/j.bbadva.2022.100052
4. Targeting Fascin1 maintains chondrocytes phenotype and attenuates osteoarthritis development.
   Yang P, Xiao Y, Chen L, Yang C, et al · · 2024 · cited 9× · PMID 39231936 · DOI 10.1038/s41413-024-00357-1
5. Effects of imipramine on cancer patients over-expressing Fascin1; description of the HITCLIF clinical trial.
   Asensi-Cantó A, Rodríguez-Braun E, Beltrán-Videla A, Hurtado AM, et al · · 2023 · cited 9× · PMID 37841433 · DOI 10.3389/fonc.2023.1238464
6. Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.
   Postigo-Corrales F, Beltrán-Videla A, Lázaro-Sánchez AD, Hurtado AM, et al · · 2025 · cited 5× · PMID 40806254 · DOI 10.3390/ijms26157119
7. Inhibitors of the Actin-Bundling Protein Fascin-1 Developed for Tumor Therapy Attenuate the T-Cell Stimulatory Properties of Dendritic Cells.
   Zeyn Y, Harms G, Tubbe I, Montermann E, et al · · 2022 · cited 5× · PMID 35681718 · DOI 10.3390/cancers14112738
8. Fascin-1 expression is associated with neuroendocrine prostate cancer and directly suppressed by androgen receptor.
   Turpin A, Delliaux C, Parent P, Chevalier H, et al · · 2023 · cited 4× · PMID 37875732 · DOI 10.1038/s41416-023-02449-x