NP-101 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called NP-101, a potential drug, to determine its safety and effectiveness for people with solid tumors. These tumors have either grown or returned after other treatments. Researchers aim to find the right dose and observe the body's reaction in two different groups. Suitable candidates for this trial have solid tumors that have worsened despite previous treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there is a requirement for a 'washout period' (time without taking certain medications) from prior therapies before starting the study treatment. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that NP-101 is likely to be safe for humans?
Research shows that NP-101 is being tested for safety in people with solid tumors. Earlier studies found NP-101 to be generally well-tolerated, focusing on determining the right dose and understanding any side effects.
As a Phase 1 study, the primary goal is to assess safety. Early research suggests that NP-101 does not cause severe side effects in most patients. However, as an experimental drug, some side effects could still occur.
Prospective participants should know that researchers closely monitor safety. They aim to ensure the treatment remains gentle on the body while maintaining effectiveness.12345Why do researchers think this study treatment might be promising?
NP-101 is unique because it targets cancer cells with a novel active ingredient that disrupts specific pathways essential for cancer cell survival. Unlike traditional chemotherapy, which often affects both healthy and cancerous cells, NP-101 aims to minimize collateral damage to healthy tissues. Researchers are excited because this targeted approach could potentially lead to fewer side effects and improved outcomes for patients.
What evidence suggests that NP-101 might be an effective treatment for cancer?
Research has shown that NP-101 could be promising for treating solid tumors. In this trial, participants will receive NP-101 in different dosing regimens, either through a Dose Escalation or Dose Expansion arm. Previous studies have combined NP-101 with other drugs like nivolumab and ipilimumab, demonstrating activity against certain types of cancer that did not respond well to chemotherapy. This treatment appears to alter the tumor environment, potentially improving patient outcomes. Although these findings are early, they offer a hopeful glimpse of NP-101's potential in fighting cancer.678910
Who Is on the Research Team?
Aung Naing, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that have worsened after treatment or lack standard options can join. They must be in good health otherwise, with proper organ/marrow function and a life expectancy over 3 months. Participants need to agree to contraception use and biopsies/blood tests. Those who've had recent treatments must wait before joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of NP-101 to determine safety and tolerability
Dose Expansion
Participants receive NP-101 at the determined safe dose to evaluate preliminary antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NP-101
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Novatek Pharmaceuticals, Inc.
Collaborator