Joint Clinical Trials Office

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 Pilot Study to Evaluate Feasibility of Intraoperative Gamma Probe Tracing of Meningioma using [Cu64] DOTATATE

The purpose of this research is to evaluate the feasibility of using the radiotracer [Cu64]DOTATATE to detect tumors intraoperatively (during surgery) for patients with meningioma.

[Cu64]DOTATATE is a U.S. Food and Drug Administration (FDA) approved PET (positron emission tomography) radiotracer for the imaging of tumors that have a specific marker on their surface (somatostatin receptor). It has not yet been evaluated on whether it can help assess the extent of tumor removed during surgery.

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 III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC

This study is being done to evaluate if maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) results in significant improvement in overall survival for patients with intermediate risk HPV positive oropharynx cancer. We are doing this study because we want to find out if this approach is better or worse than the usual approach for HPV positive oropharynx cancer. 
   

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).