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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or intolerant to other available therapies.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
22-013320
NCT ID:
NCT05448820
Sponsor Protocol Number:
YH001/KN035SAR101

Study Of NXP900 With Osimertinib In Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Study Of NXP900 With Osimertinib In Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This is a multi-center, open label, Phase 1b study of NXP900 in combination with osimertinib in subjects with advanced, progressing, EGFR-mutated non-small cell lung cancer (NSCLC)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
26-006024
NCT ID:
NCT07315113
Sponsor Protocol Number:
NXP900-103

(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.

The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.

The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%.

A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.

Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

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Site IRB:
22-011685
NCT ID:
NCT05607004
Sponsor Protocol Number:
ATOS-Z-201

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I), and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
21-002451
NCT ID:
NCT04910022
Sponsor Protocol Number:
PARPA-293-002

Muscle Protein Metabolism in Obesity
- See Details
Muscle Protein Metabolism in Obesity
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
About this study

Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese individuals. This research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The findings will help to develop appropriate interventions to improve muscle ATP turnover and metabolism in obese people.

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NCT ID:
NCT01824173

Sponsor Protocol Number:
12-004000
Plasma Triglyceride Extraction By The Muscle
- See Details
Plasma Triglyceride Extraction By The Muscle
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
About this study

Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.

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NCT ID:
NCT01860911

Sponsor Protocol Number:
12-005173

A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

See Details

A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of the study is to evaluate the impact on metastases-free survival with the addition of saruparib versus placebo to a standard RT + ADT regimen in men with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCAm.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
25-007267
NCT ID:
NCT06952803
Sponsor Protocol Number:
D9727C00001

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Search Results 1101-1110 of 11769

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Study Of NXP900 With Osimertinib In Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of BL-M05D1 In Subjects With Solid Tumors

CLEOPATTRA: A Research Study To Look At The Effects Of Treatment With A Medicine Called Coramitug (NNC6019-0001) In People With Heart Failure Due To Transthyretin Amyloid (ATTR) Amyloidosis

Mesenteric Sparing for the Prevention of Recurrent Crohn's Disease

A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma

Muscle Protein Metabolism in Obesity

Plasma Triglyceride Extraction By The Muscle

A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.

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