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Joint Clinical Trials Office

CT Open to Enrollment

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors

This study will investigate whether a new experimental treatment, ORM-5029, will be a safe and possibly effective treatment option for patients with solid tumors that have higher levels of a protein called HER2. The study is designed to find a safe and effective dose of ORM-5029.

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic TNBC

The purpose of this study is to determine whether an investigational drug called datopotamab deruxtecan (also known as Dato-DXd) is as good or better at treating locally recurrent inoperable or metastatic triple-negative breast cancer, as compared to a single standard chemotherapy. 

Dato-DXd is an investigational drug, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). The chemotherapy options used in this study are FDA-approved.

Technical Development for Fetal and Neonatal MRI

This study involves the enrollment of two patient populations. For the neonatal population, we aim to develop a more accurate and efficient method for identifying abnormalities in the newborn brain using MRI imaging. MRI is the most advanced technique to examine the newborn brain, and it does not involve radiation unlike x-rays or CT. Participation will involve a 60-minute MRI scan without any sedation or contrast injections as well as approximately 2 hours dedicated to swaddling and feeding your child in preparation for the scan.
   

Assessment of Placental Perfusion and Oxygenation Using Novel MRI Approaches

In PEPERONI (PlacEntal PERfusion and OxygeNation Imaging), we use cutting-edge imaging to monitor how well the placenta works. The placenta, a unique and vital organ, is shared by the mother and her offspring during pregnancy. In this study, we are using advanced magnetic resonance imaging (MRI) methods to assess how the placenta performs essential functions, such as perfusion (blood flow) and oxygenation.

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases

This study is evaluating the addition of stereotactic radiosurgery (SRS) before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. 

A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of KB707 in Subjects with Locally Advanced or Metastatic Solid Tumor Malignancies

This clinical trial is for men and women with locally advanced or metastatic solid tumor malignancies who have progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy.

The purpose of this study is to evaluate the safety and effectiveness of KB707. KB707 is experimental, which means that it is being tested and is not yet approved by the United States Food and Drug Administration (FDA).

A Multicentre, Phase II, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination with Venetoclax and Rituximab in Participants with Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)

This clinical trial is for men and women who have mantle cell lymphoma, a sub-type of B-cell non-Hodgkin lymphoma, who have never received treatment for their disease before.

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk TIA (LIBREXIA-STROKE)

The purpose of this study is to see if an experimental drug, called milvexian in addition to standard of care, is safe and useful in reducing the risk of future ischemic stroke in subjects after ischemic stroke or transient ischemic attack compared to placebo (tablet with no active drug) in addition to standard of care. This research is important to future patients, as this knowledge may help doctors do a better job of preventing stroke in patients.

Experimental means that milvexian has not yet been approved by the U.S. Food and Drug Administration (FDA). 

Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin may have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery. This research is important to future patients, as this knowledge may help doctors do a better job of preventing stroke in patients with major narrowing of brain arteries.

Phase II Study of Suratadenoturev (OBP-301) in Combination with Pembrolizumab in Immunotherapy Refractory Esophagogastric Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of OBP-301 with pembrolizumab in advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma (gastroesophageal adenocarcinoma).
   
OBP-301 is experimental, which means that it in combination with pembrolizumab is being tested and they are not yet approved by the United States Food and Drug Administration (FDA).