Monoclonal Antibodies

NP-G2-044 Monotherapy for Solid Tumor Malignancies

City of Hope, Duarte, CA
NP-G2-044 Monotherapy +2 morePhase 1 & 2RecruitingResearch Sponsored by Novita Pharmaceuticals, Inc.

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.

Eligible Conditions
  • Advanced or Metastatic Solid Tumor Malignancies

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are able to swallow pills.
You have been diagnosed with an advanced or spreading form of cancer that is not responding to standard treatments or cannot be treated with usual medications.
You have any type of cancer affecting the female reproductive organs, such as the ovaries, uterus, fallopian tubes, cervix, vulva, or vagina.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: NP-G2-044 Monotherapy- CapsuleExperimental Treatment1 Intervention
NP-G2-044 capsule PO QD for each 28-day cycle
Group II: NP-G2-044 Combination Therapy With Anti-PD-1 TherapyExperimental Treatment2 Interventions
NP-G2-044 capsule 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 site

Who is running the clinical trial?

Novita Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
23 Total Patients Enrolled
Jillian Zhang, Ph.D.Study Director
Novita 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, 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. 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 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?
What portion of applicants met pre-screening criteria?
Met criteria
~24 spots leftby Jun 2024