Office of Research
Clinical Trials

Leading the Future of Clinical Medicine
The College of Medicine is a hub for groundbreaking clinical research. With over 30 specialized research units, our teams are dedicated to translating laboratory discoveries into life-saving clinical applications. From neurology to oncology, we provide the infrastructure and expertise necessary to push the boundaries of modern medicine.

Browse our Research Units below to view current study listings.

Clinical Trials Search

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma | Lung Cancer

Phase 1

Study on IOV-4001 for Advanced Melanoma and NSCLC

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study on IOV-4001 for Advanced Melanoma and NSCLC
Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma

Phase 1

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/​11 Mutations or PRKC Fusions

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/​11 Mutations or PRKC Fusions
Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Skin Cancer & Sarcoma | Breast Cancer

Phase 1

AMXT1501 and DFMO With Standard Care

This open-label Phase 1b/2 study tests two oral drugs, AMXT 1501 and DFMO, given together with standard treatments in people with advanced ER+ / HER2- breast cancer or with unresectable or metastatic cutaneous melanoma. AMXT 1501 blocks tumor uptake of polyamines and DFMO lowers polyamine production; together they aim to reduce tumor-supporting molecules and possibly improve responses to standard therapy. In the breast cancer group the combo is given with fulvestrant and capivasertib. In the melanoma group the combo is given with pembrolizumab. The Phase 1b part uses a small dose-escalation plan to find a safe dose for Phase 2. The Phase 2 part will look for signs the treatment controls or shrinks tumors using standard tumor response rules. The study also checks drug levels in blood, changes in tumor tissue and immune genes, and overall safety. About 92 patients may be enrolled across the two groups. Participants will have screening tests, regular clinic visits each treatment cycle (28 days), imaging to measure response, and follow-up visits.

This study may be appropriate for those with: Metastatic Cancer

Learn More about AMXT1501 and DFMO With Standard Care
Robert Franklin, MD

Robert Franklin, MD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma | Lung Cancer | Genitourinary Cancer

Phase 1

A Study of DB-1311 in Advanced/​Metastatic Solid Tumors

This Phase 1/2a trial aims to assess the safety and tolerability of DB-1311 in patients with advanced solid tumors through dose-escalation and dose-expansion studies.

This study may be appropriate for those with: Metastatic Cancer

Learn More about A Study of DB-1311 in Advanced/​Metastatic Solid Tumors
Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 2

DB 1311 Combination Trial

This is an open-label Phase 2 study testing DB-1311 given with either BNT327 or DB-1305 in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study aims to check safety, side effects, how the body processes the drugs, and early signs of benefit like tumor shrinkage and longer time without disease growth. Eligible participants have one of several cancer types (liver cancer, cervical cancer, melanoma, head and neck cancer, platinum-resistant ovarian cancer, or non-small cell lung cancer) and meet basic health and lab criteria. People who previously received certain similar antibody-drug treatments, have serious uncontrolled illnesses, active brain metastases, autoimmune disease, or unresolved severe side effects are not allowed. Participants will receive study drugs in repeated treatment cycles and be seen regularly for safety checks, scans, and blood tests. The study may follow participants for up to about 6 years to collect long-term safety and outcome data.

This study may be appropriate for those with: Metastatic Cancer

Learn More about DB 1311 Combination Trial
Robert Franklin, MD

Robert Franklin, MD

Phase 1 - Solid Tumor

Phase 1

Study of JZP898 for Advanced/Metastatic Solid Tumors

This clinical research study is focused on understanding how a new drug called JZP898 works in adults who have advanced or metastatic solid tumors. The study is taking place in two parts. In the first part, researchers are exploring how the drug works on its own and when combined with another drug, pembrolizumab. They aim to find a safe dosage and look for any potential side effects. In the second part, they will further explore the effects of the combination of these two drugs on different types of tumors. The researchers want to know if these treatments can shrink the tumors and are safe for people to use over a long time. They will keep track of how the participants react to the treatment and measure things like how long the drug stays in their system and if it has any unwanted effects. People who want to participate must meet certain conditions, like having a specific kind of tumor and being able to care for themselves daily without too much help. This study is supported by Jazz Pharmaceuticals.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study of JZP898 for Advanced/Metastatic Solid Tumors
Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor | Skin Cancer & Sarcoma

Phase 1

Study of GIM-531 for Advanced Solid Tumors

This study examines the safety and effectiveness of a new oral drug, GIM-531, specifically aimed at treating advanced solid tumors. It's divided into two phases, with Phase 1 focusing on finding a safe dose and Phase 2 expanding to further assess its safety and initial anti-tumor activity. GIM-531 works by selectively inhibiting certain immune cells called regulatory T-cells, which may help control tumor growth. The study measures the frequency and intensity of side effects, dose limitations, and how well the drug works against tumors. Participants will be those whose cancer has worsened after other treatments and must meet specific health criteria.

This study may be appropriate for those with: Metastatic Cancer

Learn More about Study of GIM-531 for Advanced Solid Tumors