Clinical Trials

Multiple clinical trials evaluate NP-G2-044 as monotherapy and in combination regimens across advanced or metastatic solid tumors, including platinum-resistant ovarian, breast, lung, colon, pancreatic, esophageal, liver, and prostate cancers. Sponsored by Novita Pharmaceuticals Inc. in collaboration with Translational Drug Development, these Phase 1, Phase 1/2, and Phase 2/3 studies evaluate safety and tolerability in patients with treatment-refractory malignancies. The protocols encompass early dose-escalation research and maintain recruitment statuses reported as completed or active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07109414 ACTIVE_NOT_RECRUITING
Platinum-resistant Ovarian Cancer
Novita Pharmaceuticals, Inc.
2025-12-29 PHASE2; PHASE3
NCT05023486 ACTIVE_NOT_RECRUITING
Advanced or Metastatic Solid Tumor Malignancies
Novita Pharmaceuticals, Inc.
2021-12-07 PHASE1; PHASE2
NCT03199586 COMPLETED
Breast Cancer; Pancreas Cancer; Prostate Cancer; Lung Cancer; Colon Cancer; Esophagus Cancer; Liver Cancer; Ovary Cancer; Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies
Novita Pharmaceuticals, Inc.
2017-12-21 PHASE1
NCT03199586 Completed
Breast Cancer|Pancreas Cancer|Prostate Cancer|Lung Cancer|Colon Cancer|Esophagus Cancer|Liver Cancer|Ovary Cancer|Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies
Novita Pharmaceuticals Inc.|Translational Drug Development
2017-12-21 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-09)

Check the NP-G2-044 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NP-G2-044 selectively binds to fascin, inhibiting its actin-bundling activity to disrupt filopodia formation and impede the migratory capacity of tumor cells. By impairing cell motility and enhancing antitumor immune responses, this small-molecule inhibitor limits primary tumor spread, demonstrating therapeutic relevance in clinical trials targeting advanced, metastatic, and refractory solid malignancies such as platinum-resistant ovarian cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.