NCT05262556View on ClinicalTrials.gov

NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Gastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine NeoplasmNeuroendocrine CarcinomaMixed Neuroendocrine-Non Neuroendocrine Neoplasm
Interventions
DRUG

NP-101 (TQ Formula)

Oral, five 600mg tabs daily every three weeks for four cycles (21-day cycle), then maintenance for an additional 12 weeks for a total of six cycles.

DRUG

Nivolumab (3mg/kg)

Intravenously on Day 1 every three weeks for four cycles (maximum dose 360mg once every 3 weeks), then 240mg maintenance every two weeks for six cycles for a total of six months of treatment.

DRUG

Ipilimumab (1mg/kg)

Intravenously on day 1 of each (21-day) cycle for a total of four cycles only.

Trial Locations (1)

44106

University hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

Sponsors

Collaborators (1)

Novatek Pharmaceuticals
All Listed Sponsors
collaborator

Novatek Pharmaceuticals

INDUSTRY

lead

Amr Mohamed MD

OTHER

NCT05262556 - NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas | Biotech Hunter | Biotech Hunter