drugset
drugset / Trial / NCT07325123

Malic Acid Supplementation Combined With Immunotherapy in Patients With Solid Tumors

NCT07325123 ↗

Phase 0 Not yet recruiting 30 enrolled The First Affiliated Hospital of Xinxiang Medical College
NaSingle-groupOpen-labelTreatment

Summary

This is a study on the safety and efficacy of malic acid supplementation combined with immunotherapy for anti-tumor treatment in patients with solid tumors. The primary study objective is to determine the oral safety of malic acid; Secondary study objectives: 1. To evaluate the preliminary efficacy of malic acid in the study population. 2. To determine the recommended phase 2 dose (RP2D) of oral malic acid. Exploratory endpoints: Immune indicators including white blood cell count, neutrophil, lymphocyte, monocyte, eosinophil and basophil (count/proportion); metabolic indicators including blood glucose, triglycerides; nutritional indicators including body weight.

Timeline

Start
2025-12-31
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Malic Acid Small molecule 30 mg/kg Oral
Subject Malic Acid Small molecule 60 mg/kg Oral
Subject Malic Acid Small molecule 90 mg/kg Oral

Indications

No indication recorded.