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| Name | Class |
|---|---|
| Translational Drug Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP-G2-044 | Experimental | capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP-G2-044 | Drug | capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the safe recommended phase 2 dose | Treatment related adverse events assessed by CTCAE V4.03 | 24 months |
| 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) |
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Inclusion Criteria:
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
ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator
Acceptable organ and marrow function as defined below:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jillian Zhang, Ph.D. | Novita Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41707378 | Derived | 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. | |
| 33188449 | Derived | 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. |
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| 24 months |
| Tmax | Time to peak plasma concentration | 24 months |
| Cmax | Peak plasma concentration | 24 months |
| Duarte |
| California |
| 91010 |
| United States |
| Memorial Sloan Kettering Hospital | New York | New York | 10065 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008113 | Liver Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D008107 | Liver Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000729918 | NP-G2-044 |
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