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Breast CancerPhase 1NCT03199586

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

A Phase 1 study testing NP-G2-044 in people with Breast Cancer and Pancreas Cancer, run by Novita Pharmaceuticals, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Pancreas Cancer, Prostate Cancer
What is being tested?
NP-G2-044
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesUnited States
Study dates
21 Dec 2017to 7 May 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent and mental capability to understand the informed consent
  • Male or female patients > 18 years of age
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Evaluable or measurable disease per RECIST v1.1
  • Life expectancy > 3 months
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  • ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator
  • 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
  • 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.
  • Male and female patients with reproductive potential must agree to use adequate contraceptive precautions throughout the study.

Who cannot join

  • 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)
  • Participation in any other clinical investigation using an experimental drug within 4 weeks of first dose of study drug
  • 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
  • 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
  • Baseline prolongation of QT/QTc interval (QTc interval > 470 msec in women and >450 msec in men)
  • 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
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  • Women who are pregnant or breastfeeding
  • 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
  • Prior history of clinically significant gastrointestinal bleeding, intestinal obstruction or gastrointestinal perforation within 6 months of study enrollment
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Memorial Sloan Kettering Hospital

    New York, New York, 10065

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: 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.

Being tested
NP-G2-044
Keywords
Advanced or metastatic treatment-refractory solid tumor malignancies
Medical subject headings
Breast Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Liver Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NP-G2-044Drug

    capsule

Study groups in NCT03199586
Study groupRoleWhat they receive
NP-G2-044Experimentalcapsule
Receives: Drug: NP-G2-044

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establish the safe recommended phase 2 dose

    Treatment related adverse events assessed by CTCAE V4.03

    Measured: 24 months

Secondary outcomes (4)

  1. Identify and characterize preliminary anti tumor activity

    Anti tumor activity assessed using RECIST 1.1

    Measured: 24 months

  2. Characterize the pharmacokinetics of NP-G2-044

    Drug exposure assessed by area under the curve (AUC)

    Measured: 24 months

  3. Tmax

    Time to peak plasma concentration

    Measured: 24 months

  4. Cmax

    Peak plasma concentration

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2017
  2. Study start21 Dec 2017
  3. Primary completion7 May 2020
  4. Study completion7 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03199586
Sponsor's protocol ID
NP-G2-044-P1-01
Status last verified
Dec 2020
First submitted
23 Jun 2017
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maksimova K, Pustovalova M, Kuzmin DV, Leonov S, Merkher Y. Mapping metastatic potential through cytoskeletal remodeling: A mechanobiology-based multi-cancer analysis. Biochem Biophys Res Commun. 2026 Apr 9;808:153428. doi: 10.1016/j.bbrc.2026.153428. Epub 2026 Feb 14.

    PubMed 41707378

  • 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.

    PubMed 33188449

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NP-G2-044 in people with Breast Cancer and Pancreas Cancer, run by Novita Pharmaceuticals, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish the safe recommended phase 2 dose (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03199586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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