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

NCT05023486 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novita Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jillian Zhang, Ph.D. · Novita Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023486 on ClinicalTrials.gov