← Back to Search

Monoclonal Antibodies

NP-G2-044 Monotherapy/Combination for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Novita Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and bone marrow function: ANC >1500 cells/μL, Hemoglobin >9.0 g/dL, Platelet count >100,000 cells/μL, Total bilirubin ≤1.5 mg/dL, Albumin ≥3.0 g/dL, Liver enzymes within normal range, Creatinine clearance ≥50 mL/min, Prothrombin time and partial thromboplastin time within normal range
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, NP-G2-044, to see if it is safe and works well against solid tumors.

Who is the study for?
Adults over 18 with advanced solid tumors, able to swallow pills and with good organ/bone marrow function. Women of childbearing age must test negative for pregnancy; men and women must use effective contraception. Excludes those with recent significant GI issues, brain metastases, heart problems, or who've had certain transplants or treatments recently.Check my eligibility
What is being tested?
The trial is testing NP-G2-044 alone and combined with anti-PD-1 therapy in patients with advanced solid tumors. It aims to assess safety, tolerability, initial effectiveness against the tumor, how the body processes the drug (pharmacokinetics), and its action on the body (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer therapies such as nausea, fatigue, immune-related effects due to anti-PD-1 therapy component which can cause inflammation in organs like lungs or intestines but specific side effect profile for NP-G2-044 will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood, liver, and kidney functions are within normal ranges.
Select...
I am fully active or can carry out light work.
Select...
My cancer is advanced or has spread, confirmed by tissue analysis.
Select...
I am a man who is either surgically sterile or willing to use strong contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D)
Identification of the RP2D for patients receiving NP-G2-044 in combination with anti-PD-1 therapy
NP-G2-044 anti-tumor preliminary efficacy signals when administered as continuously dosed monotherapy assessed by RECIST 1.1
+3 more
Secondary outcome measures
Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-1 therapy
Combined Modality Therapy
Combined Modality Therapy
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: NP-G2-044 Monotherapy - Capsule/TabletExperimental Treatment1 Intervention
NP-G2-044 capsule/tablet PO QD for each 28-day cycle
Group II: NP-G2-044 Combination Therapy With Anti-PD-1 TherapyExperimental Treatment2 Interventions
NP-G2-044 capsules PO QD for each 28-day cycle, Anti-PD-1 Therapy per standard of care, at a dose and frequency in accordance with the package insert

Find a Location

Who is running the clinical trial?

Novita Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
23 Total Patients Enrolled
Jillian Zhang, Ph.D.Study DirectorNovita Pharmaceuticals, Inc.
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Anti-PD-1 Therapy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05023486 — Phase 1 & 2
Solid Tumor Malignancies Research Study Groups: NP-G2-044 Monotherapy - Capsule/Tablet, NP-G2-044 Combination Therapy With Anti-PD-1 Therapy
Solid Tumor Malignancies Clinical Trial 2023: Anti-PD-1 Therapy Highlights & Side Effects. Trial Name: NCT05023486 — Phase 1 & 2
Anti-PD-1 Therapy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023486 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial the inaugural of its kind?

"Since 2021, NP-G2-044 Monotherapy has been subject to ongoing exploration. Initially studied in a 100 patient trial funded by Novita Pharmaceuticals, Inc., the drug successfully passed through Phase 1 & 2 of clinical trials and is now supported by one active study conducted under their sponsorship."

Answered by AI

How many venues are hosting this experiment?

"This medical trial is being administered in 15 locations, such as the University of Kansas Cancer Centre located in Fairway, Atlantic Health System - Morristown Medical Center found in Morrisstown and University of Arkansas for Medical Sciences located in Little Rock."

Answered by AI

Could you expound on the research history of NP-G2-044 Monotherapy?

"Currently, 1 clinical trial is underway for NP-G2-044 Monotherapy with no Phase 3 studies in progress. While most of the research centres are situated in Tucson, Arizona, other locations across 15 cities have also committed to conducting medical trials on this drug."

Answered by AI

What ultimate outcome is this clinical experiment attempting to achieve?

"This study's primary objective, to be evaluated within 30 days of the last dose administered, is to gain preliminary insights into NP-G2-044's efficacy when coupled with anti-PD-1 therapy as measured by RECIST 1.1. Auxiliary goals include characterizing the drug combination's antitumor activity via iRECIST and analyzing pharmacokinetics data such as area under plasma concentration curves (AUC) and time to peak plasma concentrations (Tmax)."

Answered by AI

What is the aggregate quantity of participants in this experiment?

"Correct. Clinicaltrials.gov verifies that this medical experiment, which was first advertised on December 7th 2021, is proactively enlisting participants. A total of 100 individuals are needed to be enrolled from 15 different locations."

Answered by AI

Is enrollment in this experiment still available for participants?

"Yes, the latest information on clinicaltrials.gov affirms that recruitment for this study is still ongoing since its initial posting date of December 7th 2021. In order to complete their research goals, 100 individuals must be recruited from 15 different centres."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies
2021. "NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05023486.
~12 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top