Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
- Conditions
- Solid Tumor
- Registration Number
- NCT06563375
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age 18 years.<br><br> 2. Must be willing and able to provide informed consent.<br><br> 3. Ability to comply with the study protocol, in the investigator's judgment.<br><br> 4. Histologically documented advanced or metastatic solid tumor that has relapsed or<br> progressed following local standard treatments that are known to prolong survival,<br> or for which no standard treatment is available.<br><br> 5. For dose escalation, patients can have evaluable or measurable disease. For dose<br> expansion, patients must have measurable disease per the RECIST v1.1 (Appendix 1).<br><br> 6. Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 2).<br><br> 7. Life expectancy 3 months.<br><br> 8. Adequate organ and marrow function as defined below within 28 days of study<br> treatment initiation:<br><br> - Hemoglobin >9.0 g/dL<br><br> - Absolute neutrophil count =1500/mL<br><br> - Platelets =100,000/mL<br><br> - Total bilirubin =1.5 institutional upper limit of normal (ULN). Documented<br> Gilbert syndrome is allowed if total bilirubin is =3 × ULN.<br><br> - Aspartate transaminase/ALT =3 × institutional ULN.<br><br> - Creatinine clearance =60 mL/min.<br><br> - For patients not receiving therapeutic anticoagulation: international<br> normalized ratio or activated partial thromboplastin time =1.5 × ULN. For<br> patients receiving therapeutic anticoagulation: stable anticoagulant regimen.<br><br> 9. Left ventricular ejection fraction =50%.<br><br> 9. Patients must have adequate washout from prior therapy at the time of study<br> treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based<br> therapy; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or<br> small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from<br> chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive<br> radiotherapy, mitomycin C, and nitrosoureas); and 4 weeks from radiation therapy.<br> Palliative radiotherapy is permitted for a preexisting lesion, provided it does not<br> interfere with the assessment of tumor target lesions (e.g., the lesion to be<br> irradiated must not be a site of measurable disease).<br><br> 10. Patients with a prior or concurrent malignancy whose natural history or treatment<br> does not have the potential to interfere with the safety or efficacy assessment of<br> the investigational agent are eligible for this study.<br><br>Women of childbearing potential (WOCBP) must agree to follow the contraception guidelines<br>in Appendix 3 during the study treatment period and for at least 60 days after the last<br>dose of study treatment. A woman is considered to be of childbearing potential if she is<br>postmenarcheal, has not reached a post-menopausal state (=12 continuous months of<br>amenorrhea with no identified cause other than menopause), and is not permanently<br>infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or<br>another cause as determined by the investigator (e.g., Müllerian agenesis). Should a<br>woman become pregnant or suspect she is pregnant while she or her partner is<br>participating in this study, she should inform her treating physician immediately. Female<br>patients who become pregnant will be taken off study.<br><br> 12. Male patients of childbearing potential must agree to follow the contraception<br> guidelines in Appendix 3 during the study treatment period and for at least 60 days<br> after the last dose of study treatment.<br><br> 13. WOCBP must have a negative serum pregnancy test result within 3 days of study<br> treatment initiation.<br><br> 14. Willing to undergo mandatory tumor biopsy and blood collections as required by the<br> study.<br><br>Exclusion Criteria:<br><br> 1. History of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to the study drug.<br><br> 2. Unresolved toxicities from prior therapy (defined as having not resolved to NCI<br> CTCAE v.5.0 Grade =1 or baseline). Exceptions include endocrinopathies from prior<br> therapy or disease and successfully treated (such as hypothyroidism, diabetes<br> mellitus), alopecia, vitiligo, and Grade =2 peripheral neuropathy. Patients may be<br> enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade<br> >2 for at least 3 months prior to Cycle 1, Day 1 and managed with standard of care<br> treatment) that the investigator deems related to previous toxicities from prior<br> immunotherapy treatment.<br><br> 3. Patients who are receiving any other investigational agents.<br><br> 4. Unable to swallow and retain oral medications.<br><br> 5. Gastrointestinal (GI) tract disease causing the inability to take oral medication,<br> malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures<br> affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's<br> disease, ulcerative colitis).<br><br> 6. Known positive status for HIV infection.<br><br> 7. Known active hepatitis B virus or HCV infection.<br><br> 8. Brain or leptomeningeal metastases.<br><br> 9. Has a known additional malignancy that is progressing or requires active treatment.<br> Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the<br> skin that has undergone potentially curative therapy, or in situ cervical cancer.<br><br> 10. History or current evidence of any condition, therapy, or laboratory abnormality<br> that might confound the results of the study, interfere with the patient's<br> participation for the full duration of the study, or is not in the best interest of<br> the patient to participate, in the opinion of the investigator.<br><br> 11. Evidence of other clinically significant uncontrolled condition(s) including, but<br> not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).<br><br> 12. Active infection requiring systemic antimicrobial treatment (including antibiotics,<br> antifungals, and antiviral agents).<br><br> 13. Clinically significant cardiovascular disease within 12 months prior to enrollment,<br> including New York Heart Association Class III or IV congestive heart failure,<br> unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia<br> associated with hemodynamic instability. NOTE: medically controlled arrhythmia would<br> be permitted.<br><br> 14. Pregnant and/or breastfeeding.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method