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NP-101 for Advanced Solid Tumors

This study is testing a new targeted therapy called NP-101 for people with advanced or metastatic solid tumors. NP-101 is taken by mouth. The main goal is to see how safe NP-101 is and what side effects it might cause. Researchers will also look for any signs that NP-101 is helping to shrink tumors or relieve symptoms. You might be able to join if you are 18 or older, have an advanced solid tumor that has progressed after standard treatments, or if there are no standard treatments available for your cancer. This study aims to enroll about 35 participants.

Study design
This is a Phase 1 study, meaning it's an early-stage trial. It will enroll about 35 participants to evaluate the safety and preliminary effectiveness of NP-101.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06563375

Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~35 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:NP-101

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Solid Tumor

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NCT06563375

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aung Naing, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Aung Naing, MD
[email protected]
(713) 563-3885
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Hemoglobin \>9.0 g/dL
Absolute neutrophil count ≥1500/mL
Platelets ≥100,000/mL
Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.
Aspartate transaminase/ALT ≤3 × institutional ULN.
Creatinine clearance ≥60 mL/min.
For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen. 9. Left ventricular ejection fraction ≥50%.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0