Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
M.D. Anderson Cancer Center
Summary
To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.
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 pha…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 perfo…
Interventions
- DrugNP-101
Given by mouth
Location
- MD Anderson Cancer CenterHouston, Texas