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

NCT06563375 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2024-0500NCI-2024-06908
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

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

  Through study completion; an average of 1 year.

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Drug: NP-101

Dose Expansion

EXPERIMENTAL

Drug: NP-101

Interventions

NP-101 DRUG

Given by mouth

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years.
• Must be willing and able to provide informed consent.
• Ability to comply with the study protocol, in the investigator's judgment.
• 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.
• For dose escalation, patients can have evaluable or measurable disease. For dose expansion, patients must have measurable disease per the RECIST v1.1 (Appendix 1).
• Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 2).
• Life expectancy 3 months.
• Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
• 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.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.
• Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline). Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy. Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \>2 for at least 3 months prior to Cycle 1, Day 1 and managed with standard of care treatment) that the investigator deems related to previous toxicities from prior immunotherapy treatment.
• Patients who are receiving any other investigational agents.
• Unable to swallow and retain oral medications.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).
• Known positive status for HIV infection.
• Known active hepatitis B virus or HCV infection.
• Brain or leptomeningeal metastases.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.
• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).
• Active infection requiring systemic antimicrobial treatment (including antibiotics, antifungals, and antiviral agents).
• Clinically significant cardiovascular disease within 12 months prior to enrollment, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.
• Pregnant and/or breastfeeding.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novatek Pharmaceuticals, Inc.: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aung Naing, MD

CONTACT

(713) 563-3885; anaing@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)