Oral AMXT 1501 Dicaprate in Combination With IV DFMO
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- STATUS
- Recruiting
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- End date
- Dec 31, 2023
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- participants needed
- 56
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- sponsor
- Aminex Therapeutics, Inc.
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.
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.
Details
| Condition | Cancer, Solid Tumor, Solid Carcinoma, Advanced Cancer, DIPG Brain Tumor, Ovary Cancer, Breast Cancer, Papillary Thyroid Cancer, Head and Neck Cancer, Gastric Cancer, Nsclc, Mesotheliomas Pleural, Mesothelioma Peritoneum, Esophageal Cancer, Diffuse Midline Glioma, H3 K27M-Mutant, Endometrial Cancer, Cervical Cancer, Melanoma, Colorectal Cancer |
|---|---|
| Treatment | DFMO, AMXT1501 |
| Clinical Study Identifier | NCT05500508 |
| Sponsor | Aminex Therapeutics, Inc. |
| Last Modified on | 4 October 2022 |
Eligibility
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