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Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06563375•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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

Detailed Description

Primary Objective: To determine the safety and tolerability of NP-101 in patients with solid tumors. Secondary Objective: To determine the preliminary antitumor activity of NP-101. Although the clinical benefit of NP-101 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Exploratory Objectives: To evaluate immune-related markers of response and resistance to NP-101. To bank blood samples for future pharmacokinetic (PK) analyses of NP-101.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years.
•2. Must be willing and able to provide informed consent.
•3. Ability to comply with the study protocol, in the investigator's judgment.
•4. 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.
•5. 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).
•6. Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 2).
•7. Life expectancy 3 months.
•8. 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
+12 more criteria

Exclusion Criteria

•1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.
•2. 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.
•3. Patients who are receiving any other investigational agents.
•4. Unable to swallow and retain oral medications.
•5. 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).
•6. Known positive status for HIV infection.
•7. Known active hepatitis B virus or HCV infection.
•8. Brain or leptomeningeal metastases.
•9. 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.
•10. 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.
+4 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 5, 2025

Primary Completion Date

September 1, 2028

Completion Date

September 1, 2030

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Solid Tumor

Interventions

NP-101

DRUG

Contacts

Aung Naing, MD

CONTACT

(713) 563-3885 anaing@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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