Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer; Prostate Cancer; Colon Cancer; Pancreas Cancer; Liver Cancer; Ovary Cancer; Esophagus Cancer; Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies
• Intervention / Treatment: Drug: NP-G2-044

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent and mental capability to understand the informed consent
2. Male or female patients > 18 years of age
3. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancies either treatment-refractory or otherwise ineligible for treatment with standard-of-care agents/regimens
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
5. Evaluable or measurable disease per RECIST v1.1
6. Life expectancy > 3 months
7. ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator

8. Acceptable organ and marrow function as defined below:

   • Absolute neutrophil count > 1,500 cells/μL
   • Hemoglobin ≥ 9.0 g/dL
   • Platelets > 100,000 cells/μL
   • Total bilirubin ≤ 1.5 mg/dL
   • Albumin ≥ 3 g/dL
   • Aspartate aminotransferase (AST)/alanine transaminase (ALT)/alkaline phosphatase (ALP)/Gamm-glutamyl transferase (GGT) ≤ 2.5 times ULN. For Phase 1A only, if liver metastases are present, AST/ALT/ALP < 5 times ULN
   • Serum creatinine < 1.5 mg./dL and a measured creatinine clearance ≥ 60 mL/min
   • Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 times ULN
9. Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, e.g., greater than 45 years) must have a negative serum pregnancy test prior to first dose of study drug.
10. Male and female patients with reproductive potential must agree to use adequate contraceptive precautions throughout the study.

Exclusion Criteria:

1. Chemotherapy, radiotherapy or other anti-cancer treatment within 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) of the first dose of study drug or patients who in opinion of Investigator have not recovered from AEs due to agents administered greater than 4 weeks earlier (prior immunotherapy is allowed)
2. Participation in any other clinical investigation using an experimental drug within 4 weeks of first dose of study drug
3. Failure to recover to ≤ grade 1 toxicity (except grade 1-2 alopecia or neuropathy) associated with previous chemotherapy, radiotherapy, biologic, hormone or prior investigational therapy
4. Known untreated brain metastases or treated brain metastases that have not been radiographically and clinically stable (i.e. not requiring steroids) ≥ 4 weeks prior to study enrollment
5. Baseline prolongation of QT/QTc interval (QTc interval > 470 msec in women and >450 msec in men)
6. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in opinion of Investigator would limit compliance with study requirements
7. Women who are pregnant or breastfeeding
8. Prior allogenic hematopoietic stem cell transplant or allogenic bone marrow transplant or prior solid organ transplant or current use of immuno suppression drugs or anti-transplant rejection drugs
9. Prior history of clinically significant gastrointestinal bleeding, intestinal obstruction or gastrointestinal perforation within 6 months of study enrollment
10. Sponsor reserves right to exclude any patient from the study on basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NP-G2-044; capsule	Drug: NP-G2-044; capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the safe recommended phase 2 dose	Treatment related adverse events assessed by CTCAE V4.03	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify and characterize preliminary anti tumor activity	Anti tumor activity assessed using RECIST 1.1	24 months
Characterize the pharmacokinetics of NP-G2-044	Drug exposure assessed by area under the curve (AUC)	24 months
Tmax	Time to peak plasma concentration	24 months
Cmax	Peak plasma concentration	24 months

Collaborators and Investigators

• Sponsor: Novita Pharmaceuticals, Inc.
• Collaborators: Translational Drug Development
• Investigators: Study Director: Jillian Zhang, Ph.D., Novita Pharmaceuticals

Publications and helpful links

General Publications

• Sever S. Role of actin cytoskeleton in podocytes. Pediatr Nephrol. 2021 Sep;36(9):2607-2614. doi: 10.1007/s00467-020-04812-z. Epub 2020 Nov 13.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Advanced or metastatic treatment-refractory solid tumor malignancies
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pancreatic Diseases; Esophageal Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: NP-G2-044-P1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No