NCT05023486

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Novita Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced or Metastatic Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	NP-G2-044 Monotherapy	1600 mg QD, 2000mg QD, and 2100 mg QD
DRUG	Anti-PD-1 Therapy	previously initiated per standard of care, at a dose and frequency in accordance with the package insert
DRUG	NP-G2-044 Combination therapy	1600 mg QD or 2100 mg QD

Timeline

• Start date: 2021-12-07
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-08-26
• Last updated: 2026-04-14

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study