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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
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.
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
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