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

This study is evaluating whether a new device can be used to treat 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

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Tiragolumab + Atezolizumab/Other Therapies for Cancer

This study is evaluating whether a drug which targets a specific protein may help treat cancer.

I haven't had any cancer treatment, including chemotherapy or radiotherapy, in the last 3 weeks.

I haven't had any other cancers in the last 5 years.

I have not had a severe infection in the last 4 weeks.

My blood and organs are functioning well.

My cancer is advanced and didn't respond well to standard treatments.

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

I have a brain tumor or untreated brain cancer spread.

My cancer has spread to the lining of my brain and spinal cord.

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

I have a history of lung scarring or inflammation.

Atezolizumab

Bevacizumab

Capecitabine

Carboplatin

Cisplatin

Paclitaxel

Pembrolizumab

Pemetrexed

Tiragolumab

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

This study is evaluating whether a combination of drugs may help patients with a certain type of 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

This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available. The study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of SM08502 administered orally, once daily, following a 28-day treatment cycle (Part 1A). Alternative dosing schedules will be explored in Part 1B and the recommended Part 2 dose and schedule will be further evaluated in Part 2.

Subjects will participate in a screening period of up to 14 days. Dosing in 28-day cycles will continue within each subject, unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.

Approximately 10 subjects enrolled in Part 2, irrespective of the tumor type, will be included in a food effect substudy to assess the preliminary effect of a high-fat, high-calorie meal on the PK of SM08502. Subjects participating in the food effect substudy will continue on study and complete assessments as per the Part 2 schedule and receive SM08502 at the recommended Part 2 dose (or another previously assessed dose level and schedule).

A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

SM08502 for Cancer

I can provide a sample of my tumor for the study.

I have brain metastasis that is untreated, getting worse, or causing symptoms.

I have a retinal condition like diabetic retinopathy or macular degeneration.

My advanced cancer hasn't responded to or I can't tolerate standard treatments.

I have an active HIV, HBV, or HCV infection.

I am fully active or have some restrictions but can still care for myself.

I haven't had a heart attack in the last year and don't have severe heart failure or significant heart disease.

My liver is not working well (Child-Pugh B or C).

I have no side effects from previous cancer treatments.

I am a man who can father children and agree to follow contraceptive guidelines.

I am currently on IV antibiotics for an infection.

I had another type of cancer but have been free of it for over 3 years.

I do not have a GI condition that affects medication absorption.

My heart's electrical system has a slight irregularity.

SM08502

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.

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors

FF-10832 for Cancer

This study is evaluating whether a new drug may help treat solid tumors.

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

All Individual Drugs Already Approved

This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

Long Term Extension Trial of Setmelanotide

Long-Term Setmelanotide for Obesity

This study is evaluating whether a drug which increases appetite may help treat obesity.

You have thought about or attempted suicide in the past.

I or my close family have had melanoma, or I have a history of albinism.

If the patient exhibited a clinically meaningful benefit (efficacy) to setmelanotide treatment, and would benefit from continued treatment, he/she may be eligible for the extension study, after discussion with the Sponsor.

I am over 2 years old and have safely benefited from a prior setmelanotide trial.

I have serious skin conditions related to melanoma, not including minor skin cancers.

I have a history of serious liver disease.

My kidney function is low, with a GFR under 30 mL/min.

I have been diagnosed with a psychiatric disorder like schizophrenia or depression.

My condition is actively affecting my health.

There may be other requirements for participating in the study that are not listed here.

Setmelanotide

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

This study is evaluating whether a drug may help treat colorectal cancer, stomach cancer, and kidney cancer.

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 is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091.

ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies.

VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128.

The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations:

Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies
Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum)
Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease

Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease:

Patients in Cohort 1a will receive ATP128 as single agent
Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091
Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091

Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

ATP128 + VSV-GP128 + BI 754091 for Colorectal Cancer

I have a liver lesion that can be biopsied multiple times.

I can take care of myself and am up and about more than half of my waking hours.

This is a specific group within the study.

My side effects from previous treatments are mild, except for possible hair loss, mild nerve pain, or tiredness.

My heart health does not meet the specific criteria listed, including issues with my heart's rhythm or a low ejection fraction.

My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.

I am not allergic to any of the drugs or their components used in this study.

I haven't had major surgery in the last 3 months.

I haven't had chemotherapy or targeted therapy in the last 15 days.

I have had standard treatments for stage IV colon cancer.

I have not had experimental immunotherapy or drugs targeting PD-1, PD-L1, or CTLA-4.

I am not on high-dose steroids or immunosuppressants.

I have a cancer lesion that can be safely biopsied twice.

My kidney function, measured by creatinine clearance, is good.

I need skin medication that affects my immune system.

I have an autoimmune disease, but it's not vitiligo or childhood asthma.

I am not pregnant or breastfeeding and either cannot become pregnant or will use effective birth control.

I have not received any live vaccines in the last 30 days.

My liver enzymes are within the required limits.

My cancer did not worsen after receiving initial chemotherapy.

You are expected to live for at least one year.

I have been treated with VSV-based therapy before.

This applies to all groups of people in the study.

I have undergone more than one treatment for stage IV disease.

Participants are expected to live for at least 3 more months.

I have had pneumonitis in the last 5 years.

I am eligible for surgery to remove liver metastases and possibly the primary tumor with the goal of no visible cancer remaining.

I haven't taken any monoclonal antibody treatments recently, except for Avastin, Erbitux, or Vectibix.

My bilirubin levels are within the normal range, or I have Gilbert's Syndrome with acceptable bilirubin levels.

I have no other cancers needing treatment or that have been active in the last 2 years, except for minor skin cancers or other specific non-aggressive types.

I had treatment for stage II or III colorectal cancer, but it's been over 6 months since that treatment ended.

I completed my first round of treatment for stage IV disease and my condition is stable or improved.

I have or had lung inflammation that needed steroids, or my oxygen level is below 92% without aid.

My stage IV colon cancer has spread to the liver only.

I can take care of myself and perform daily activities.

I have not taken Tamoxifen in the last month.

You are expected to live for at least 6 more months.

I have been vaccinated against metastatic colorectal cancer.

I have been diagnosed with brain swelling.

My stage IV colon cancer has not responded to standard treatments.

I have stage IV colon cancer and standard treatments haven't worked for me.

You are expected to live for at least 3 more months.

I have had standard chemotherapy for stage IV colon cancer.

My kidney, liver, and blood tests are normal as of last week.

I have undergone initial standard treatment for stage IV disease.

My kidney, liver, thyroid, and blood tests are all within normal ranges.

I agree to use birth control and not donate sperm for 6 months after my last treatment dose.

I haven't had any radiotherapy in the last 2 weeks, or 4 weeks if it was for my brain, and I've recovered from any side effects.

I am currently being treated for a long-term or active infection.

My cancer has spread to my brain or its coverings.

You are able to understand the study and are willing to provide written permission to participate.

ATP128

BI 754091

VSV-GP128

This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination stage, and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. imvotamab will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

Imvotamab for Non-Hodgkin's Lymphoma

I have a tumor larger than 1.5cm detectable by CT scan.

I am over 18 and can care for myself with minimal assistance.

I cannot have a stem cell transplant due to my condition or choice.

My cancer did not respond to CAR-T therapy, and it's been less than 3 months since that treatment.

I had a stem cell transplant less than 100 days before starting IGM-2323 treatment.

My lymphoma has returned or didn't respond to treatment.

My condition did not improve after at least two treatments, including one with anti-CD20.

I have had a transplant from another person.

Honor Health Clinical Trials 2022

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