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Cancer Vaccine

NP-101 for Cancer

Phase 1
Waitlist Available
Led By Aung Naing, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically documented advanced or metastatic solid tumor that has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available
Eastern Cooperative Oncology Group performance status of 0 or 1
Must not have
Known active hepatitis B virus or HCV infection
Brain or leptomeningeal metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

"This trial aims to test if NP-101 is safe and potentially effective for treating patients with solid tumors."

Who is the study for?
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.
What is being tested?
The trial is testing NP-101's safety and early effectiveness on various solid tumors. It has two parts: first, finding the right dose (dose escalation), then seeing how well it works at that dose (dose expansion). Patients will take NP-101 orally.
What are the potential side effects?
Specific side effects of NP-101 are not listed but may include typical reactions seen with cancer drugs such as nausea, fatigue, allergic responses, or issues related to organ functions affected by the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or worsened after treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active hepatitis B or C infection.
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My cancer has spread to my brain or its linings.
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I still have side effects from previous cancer treatments.
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I cannot swallow or keep down oral medications.
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I have a GI condition that affects my ability to take pills.
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I have another cancer that is getting worse or needs treatment.
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I am currently on medication for an infection.
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I do not have any uncontrolled infections or other serious health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Group II: Dose EscalationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,666 Total Patients Enrolled
Aung Naing, MDPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
1,742 Total Patients Enrolled
~23 spots leftby Sep 2028
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