drugset
drugset / Trial / NCT05500508

Oral AMXT 1501 Dicaprate in Combination With IV DFMO

NCT05500508 ↗

Phase 1/2 Terminated 15 enrolled Aminex Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-11-29
Primary completion
2024-12-12
Completion
2024-12-12

Outcome

Outcome not reported

Stopped: “Required re-formulation of DFMO from IV to capsule to maintain safety”

Drugs

EvaluationDrugModalityDoseRoute
Subject AMXT 1501 Small molecule 1200 mg Oral
Subject DL-2-(difluoromethyl) ornithine monohydrochloride Unknown — Intravenous

Indications

breast cancer cervical cancer colorectal cancer diffuse midline glioma, H3 K27M-mutant endometrial cancer esophageal cancer gastric cancer head and neck cancer malignant peritoneal mesothelioma malignant pleural mesothelioma melanoma non-small cell lung carcinoma ovarian cancer thyroid gland papillary carcinoma