No Placebo-Only Group

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Expanded Clinical Study of the Tendyne Mitral Valve System

Tendyne Mitral Valve System for Mitral Regurgitation

I have a blood clot in my heart's left side.

I have a chest condition that prevents certain medical procedures.

I have severe narrowing in my neck arteries causing symptoms.

I need drugs or devices to help my heart pump during my planned procedure.

I have no surgeries planned 30 days before or after the implant procedure.

I have not had a heart attack in the last 30 days.

I have not had a stroke in the last six months.

I am currently on antibiotics for an infection.

I have high blood pressure in the arteries of my lungs.

I have severe leakage in my heart's mitral valve.

I am not allergic to contrast dyes, blood thinners, nickel, or titanium.

I am unable or unwilling to give consent for treatment.

Your heart's left ventricle is larger than 7.0 cm when it's full of blood.

I am on hemodialysis for chronic kidney failure.

A team of heart specialists has decided I can't have standard heart surgery.

I have severe heart artery blockages that haven't been treated with stents or surgery.

I have health issues not related to my heart that may shorten my life to under a year.

I have a heart condition, but it's not due to dilated cardiomyopathy.

I have blood disorders that cannot be treated effectively.

Your heart's pumping ability is very low, as shown by a heart ultrasound.

I had endocarditis less than 6 months ago.

My heart condition affects my daily life even with treatment.

I am unable or unwilling to follow the study's required tests and visits.

I have severe issues with my heart's tricuspid valve or right ventricle.

I have had surgery or a procedure on my heart valves.

Tendyne Mitral Valve System

Drug Has Already Been Approved

Pivotal Trial

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Dabrafenib and/or Trametinib Rollover Study

Dabrafenib + Trametinib Access for Cancer

I had side effects from dabrafenib/trametinib that stopped my treatment.

I am currently on dabrafenib/trametinib treatment in a Novartis or GSK study.

My treatment is approved and covered by insurance in my country.

Dabrafenib

Trametinib

To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors including biliary tract cancer

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer

FF-10832 for Cancer

I have had 3 or fewer treatments for my cancer.

I haven't had treatments known to extend life by 3 months.

I have not used IV antibiotics for an infection in the last week.

My cancer has spread, doesn't respond to standard treatments, or has no treatment expected to extend life by 3 months.

My cancer is confirmed to be cholangiocarcinoma, gall bladder carcinoma, or metastatic pancreatic adenocarcinoma and cannot be surgically removed.

I have recovered from my last cancer treatment and it's been at least 3 weeks.

I can carry out all my self-care but cannot do heavy physical work.

My cancer did not respond or was not eligible for FGFR/IDH mutation treatments.

My cancer has worsened after treatment with gemcitabine and possibly cisplatin.

Gemcitabine Liposome Injection

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.

Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

Gevokizumab + Standard Cancer Therapy for Colorectal and Gastroesophageal Cancers

Your blood test shows high levels of a protein called hs-CRP.

My colorectal cancer is in its first stage of spreading.

I have a weakened immune system or an infection.

I am not taking any medications that are not allowed in the study.

I have brain metastases that cause symptoms or need specific treatment.

I have clear-cell renal cancer, treated with an anti-angiogenic agent but it progressed.

My cancer has spread, cannot be removed by surgery, and I have tissue samples available.

I do not have conditions that increase my bleeding risk with anti-VEGF treatments.

I am not taking any strong medication or supplements that affect liver enzymes.

My stomach or esophagus cancer has worsened after first-line chemotherapy including platinum and fluoropyrimidine.

I have a GI condition that could affect how my body absorbs medication.

I have at least one tumor that can be measured on a scan.

I haven't had serious heart problems in the last 6 months.

My colorectal cancer has worsened after first-line treatment including a fluoropyrimidine and oxaliplatin.

Gevokizumab

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

XmAb24306 + Atezolizumab for Solid Tumors

This trial is testing a new drug, XmAb24306, alone or with another drug to help the immune system fight advanced or spreading cancers. It aims to see if this combination can better target and destroy cancer cells.

I have had cancer spread to the lining of my brain and spinal cord.

My blood and organs are functioning well.

I have had a previous transplant of stem cells or an organ.

I am fully active or can carry out light work.

You currently have or have had a condition where your immune system attacks your own body (autoimmune disease) or your immune system is not working properly (immune deficiency).

I do not have active tuberculosis, hepatitis B or C, or Epstein Barr virus.

I have brain metastases that are causing symptoms or getting worse.

My doctor expects me to live for at least 12 more weeks.

I have not had any cancer other than the one I'm being treated for in the last 3 years.

I am taking medication that affects my heart's rhythm.

My cancer is advanced, has come back, or spread and cannot be cured.

My blood thinner medication dose has been stable.

We need a sample of your tumor for testing.

Atezolizumab

XmAb24306

TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors.

The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab.

Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.

A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors

TAK-981 + Pembrolizumab for Solid Cancers

I am taking or need to take strong medication that affects liver enzymes.

I had major surgery less than 14 days ago and haven't fully recovered.

I am currently being treated for an infection.

I stopped an immune therapy due to side effects.

My cancer is advanced and cannot be removed by surgery.

I haven't had serious heart issues in the last 6 months.

I have had lung inflammation or lung disease that needed steroids.

I have recovered from side effects of my previous treatment, or they are stable.

I have lung inflammation not caused by an infection.

I am fully active or restricted in physically strenuous activity but can do light work.

I have untreated or uncontrollable brain cancer spread.

I have not had another type of cancer in the last 3 years.

I take more than 10 mg/day of prednisone or similar drugs for an autoimmune disease.

Pembrolizumab

TAK-981

ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

AMXI-5001 for Advanced Cancers

This trial tests a new drug, AMXI-5001, for adults with advanced cancers who haven't been helped by other treatments. The drug is taken by mouth and works by stopping cancer cells from repairing and growing. The study aims to find the best dose and see how safe and effective the drug is.

I haven't taken any strong CYP3A4 affecting drugs or eaten grapefruit in the last week.

My cancer can be measured or evaluated using scans or tests.

My cancer has worsened despite treatment.

I do not have any major organ system diseases.

I do not have serious heart disease or abnormal heart tests.

My cancer is advanced or has spread to other parts of my body.

My cancer has not responded to any treatment known to work.

I cannot tolerate my current treatment due to side effects.

I have had another type of cancer besides the one being targeted, within the last 2 years.

I am currently undergoing cancer treatment.

AMXI-5001

This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.

Study Evaluating the Ketogenic Diet in Patients with Metastatic Pancreatic Cancer

Ketogenic Diet for Pancreatic Cancer

I do not have any severe illnesses like serious heart conditions.

I have had diabetic ketoacidosis in the past.

I do not have any ongoing serious infections needing treatment.

Your tumors can be measured using specific guidelines called RECIST 1.1.

I do not have severe numbness or pain in my hands or feet.

You have signs of cancer that has spread to the brain or spinal cord.

You are expected to live for at least 12 more weeks.

I have been cancer-free for over 2 years, except for specific non-threatening cancers.

Your blood's ability to clot is within the normal range, or slightly above it. If you are taking blood-thinning medication, the doctor may decide if you can still participate in the study.

My blood and organ functions are within normal ranges.

My BMI is below 18, indicating severe malnutrition.

I can follow the study's rules on birth control and pregnancy testing.

I have not had major surgery in the last 4 weeks, except for a port-a-cath insertion.

I haven't had treatments for my metastatic pancreatic disease yet.

I have been diagnosed with Type 1 diabetes.

Your albumin levels are lower than 3.0 g/dL.

My pancreatic cancer has spread and hasn't been treated yet.

I will not have unprotected sex during and for 6 months after the study.

I am able to care for myself but may not be able to do active work.

I have been diagnosed with HIV, hepatitis B, or hepatitis C.

Ketogenic Diet

This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.

Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis

Bronchial Rheoplasty for Chronic Bronchitis

I have a lung spot that might need treatment during the study.

I need more than 10 mg of oral steroids daily for my condition.

I have an ongoing lung infection that hasn't healed.

I have been on long-term lung medication or tried it in the past year without improvement.

I cannot walk more than 225 meters in 6 minutes.

I do not have any serious health conditions that could affect my safety or the study results.

Your lung function is at least 30% of what is expected for someone of your age and size after using a bronchodilator.

I have severe lung damage that affects my cough and mucus production.

My CT scan shows I have significant emphysema.

I have had lung surgery or procedures but no lung resection.

I have had a cough with mucus for 3 months each year for 2 years, and other causes have been ruled out.

Your lung function test shows a certain ratio is too low.

I have been diagnosed with severe pulmonary hypertension.

I had a serious heart rhythm problem in the last 2 years but it's treated now.

I have smoked the equivalent of 10 packs of cigarettes a year.

You have used any kind of smoking or vaping, including tobacco and marijuana, in the last 6 months.

I have severe acid reflux that isn't managed by my current treatment.

Your answers to the first two questions add up to at least 7 points, or they add up to 6 points and your total score is more than 20 points.

RheOx Bronchial Rheoplasty

Sham Procedure

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury.

Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

MT-3921 for Spinal Cord Injury

I do not have any injuries that would affect my participation in the study's required tests.

You have a problem with using drugs that affect your mind.

I have a penetrating injury to my spinal cord.

I am currently pregnant or breastfeeding.

I have a cervical spinal cord injury classified as AIS A, B, or C, with specific motor activity and BMI <40.

I have had a severe injury with an ISS score over 25.

My spinal injury is classified as AIS A, B, or C.

Your body mass index (BMI) is less than 40.

I have had cancer within the last 3 years.

My upper body strength score is 28 or less.

My spinal cord injury is between my neck and mid-back, with some arm movement.

MT-3921

Placebo

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

IDE397 for Solid Tumors

This trial is testing IDE397, a new drug, in adults with advanced cancers that don't respond to usual treatments. The drug works by blocking a protein that cancer cells need to grow.

I have brain metastases that are causing symptoms.

I have not had radiation therapy in the last 2 weeks.

I have recovered from the side effects of my last treatment.

You cannot participate if you are currently taking another experimental drug being tested in a study.

I have an ongoing liver or bile duct condition.

I can do most of my daily activities but may need help after talking to a medical expert.

I have had radiation to more than a quarter of my bone marrow.

My cancer has worsened after treatment or I cannot tolerate standard therapy.

I haven't had cancer treatment or major surgery in the last 4 weeks.

I have been treated with a MAT2A or PRMT inhibitor before.

I am using or might need strong CYP3A4/5 inhibitors or inducers.

Honor Health Clinical Trials 2022

Trials at this site

AMXI-5001 for Advanced Cancers

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