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RECRUITING Phase 1

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

NCT05023486 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG NP-G2-044 Monotherapy
  • DRUG Anti-PD-1 Therapy
  • DRUG NP-G2-044 Combination therapy

Study Locations (18)

California

  • City of Hope — Duarte
  • City of Hope Irvine Lennar — Irvine
  • Hoag Memorial Hospital Presbyterian - Gynecologic Oncology Associates — Newport Beach

Arizona

  • Honor Health Research Institute — Scottsdale
  • University of Arizona - Cancer Center — Tucson

Ohio

  • University of Cincinnati (UC) - Cancer Institute — Cincinnati
  • University Hospitals Cleveland Medical Center — Cleveland

Virginia

  • Virginia Cancer Specialists — Fairfax
  • Virginia Commonwealth University - Massey Cancer Center — Richmond

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Connecticut

  • Nuvance Health — Norwalk

Florida

  • University of Florida (UF) - Shands Cancer Center — Gainesville

Indiana

  • Indiana University (IU) Melvin and Bren Simon Cancer Center — Indianapolis

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2021-12-07
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

Novita Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05023486

The ClinicalTrials.gov registry entry for NCT05023486 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novita Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced or Metastatic Solid Tumor Malignancies appearing as the primary indexed condition, and to 3 interventions — of which NP-G2-044 Monotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05023486 reports 18 study locations spanning 13 distinct geographic areas — top geographies include California, Arizona, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05023486 about?

NCT05023486 is a clinical study titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies". 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.

What is the current status of trial NCT05023486?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2021-12-07. Estimated completion is 2026-09-30.

What conditions does trial NCT05023486 study?

This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumor Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05023486?

The interventions under investigation include: NP-G2-044 Monotherapy (DRUG), Anti-PD-1 Therapy (DRUG), NP-G2-044 Combination therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05023486?

This trial is sponsored by Novita Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05023486 being conducted?

This trial has 18 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial