Actively Recruiting
Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-03-12
35
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
Novatek Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.
CONDITIONS
Official Title
Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to provide informed consent
- Able to comply with the study protocol as judged by the investigator
- Histologically confirmed advanced or metastatic solid tumor that has relapsed or progressed after standard treatments or has no standard treatment available
- For dose escalation, evaluable or measurable disease; for dose expansion, measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and marrow function within 28 days before starting treatment, including hemoglobin >9.0 g/dL, absolute neutrophil count ≥1500/mL, platelets ≥100,000/mL, total bilirubin ≤1.5 times upper limit of normal (ULN), AST/ALT ≤3 times ULN, creatinine clearance ≥60 mL/min, and stable coagulation status
- Left ventricular ejection fraction ≥50%
- Adequate washout from prior therapies before starting study treatment according to specified timeframes
- Patients with prior or concurrent malignancies that do not interfere with study assessments are eligible
- Women of childbearing potential must follow contraception guidelines during treatment and for 60 days after last dose
- Male patients of childbearing potential must follow contraception guidelines during treatment and for 60 days after last dose
- Women of childbearing potential must have a negative pregnancy test within 3 days before treatment
- Willing to undergo mandatory tumor biopsy and blood collections as required by the study
You will not qualify if you...
- History of allergic reactions to compounds similar to NP-101
- Unresolved toxicities from prior therapy greater than Grade 1 except certain stable and managed conditions
- Receiving other investigational agents
- Unable to swallow or retain oral medications
- Gastrointestinal diseases that prevent oral medication absorption or cause malabsorption
- Known HIV infection
- Known active hepatitis B or C infection
- Brain or leptomeningeal metastases
- Additional progressing malignancy requiring active treatment, except certain skin and cervical cancers
- Any condition or abnormality that may interfere with study participation or results in the investigator's opinion
- Clinically significant uncontrolled conditions including systemic infections
- Active infections requiring systemic antimicrobial treatment
- Significant cardiovascular disease within 12 months prior to enrollment, except medically controlled arrhythmia
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Aung Naing, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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