Study #2025-0133
A phase I/II, dose-escalation and dose-optimization study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MT-4561 in patients with various advanced solid tumors and to evaluate effect of MT-4561 on pharmacokinetics of oral midazolam
MD Anderson Study Status
Enrolling
Treatment Agent
MT-4561
Description
This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts. Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design. The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer, Gastric Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Prostate Cancer, Urothelial Carcinoma, Neuroendocrine Tumor (NET), Neuroendocrine Carcinoma (NEC), Soft Tissue Sarcoma, Nuclear Protein in Testis (NUT) Carcinoma
Study phase:
Physician name:
Sarina Piha-Paul
Department:
Investigational Cancer Therapeutics
For general questions about clinical trials:
1-877-632-6789
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