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Clinical Trial Summary

A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.


Clinical Trial Description

The objective of this study is to determine the safety and tolerability of oral AMXT 1501 dicaprate (AMXT1501) in combination with IV DFMO in patients with advanced solid tumors, or DIPG/DMG. Secondary objectives include characterization of plasma pharmacokinetics (PK), pharmacodynamic (PD), and other biomarker efficacy assessments of the impact of AMXT 1501 in combination with IV DFMO on polyamine uptake by circulating lymphocytes (blood cells). To these aims, the study will evaluate the safety, PK, PD, and other biomarker efficacy profiles of orally-administered AMXT 1501 and IV DFMO. Approximately, 56 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMXT 1501 and IV DFMO in combination. The MTD is defined as the highest dose level below at which dose escalation is stopped. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Cancer
  • Breast Cancer
  • Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Cancer
  • Gastric Cancer
  • Glioma
  • Glioma, Malignant
  • Head and Neck Cancer
  • Melanoma
  • Mesothelioma
  • Mesothelioma Peritoneum
  • Mesothelioma, Malignant
  • Mesotheliomas Pleural
  • Nsclc
  • Ovarian Neoplasms
  • Ovary Cancer
  • Papillary Thyroid Cancer
  • Solid Carcinoma
  • Solid Tumor
  • Thyroid Cancer, Papillary

NCT number NCT05500508
Study type Interventional
Source Aminex Therapeutics, Inc.
Contact Project Manager
Phone 910 240 3498
Email priyanka.varma@iqvia.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 29, 2022
Completion date September 30, 2024

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