NCT06563375

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	NP-101	Given by mouth

Timeline

• Start date: 2025-03-05
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2024-08-20
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study