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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
A Phase 1 Trial Of MK-4280 As Monotherapy And In Combination With Pembrolizumab With Or Without Chemotherapy Or Lenvatinib (E7080/MK 7902) In Subjects With Advanced Solid Tumors
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 safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RPTD) for MK-4280 in combination with pembrolizumab in participants with advanced solid tumors.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
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Site IRB:
17-007205NCT ID:
NCT02720068Sponsor Protocol Number:
MK-4280-001
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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
First In Human Study Of TUB-030 In Patients With Advanced Solid Tumors
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 goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
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Site IRB:
25-001340NCT ID:
NCT06657222Sponsor Protocol Number:
5-STAR 1-01
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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
A Study Of XMT-1660 In Participants With Solid Tumors
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
The purpose of this study is to test the safety and side effects of a drug called XMT-1660.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
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Site IRB:
25-002446NCT ID:
NCT05377996Sponsor Protocol Number:
MER-XMT-1660-1
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Jacksonville, FL, Rochester, MN
Efficacy, Safety, And Tolerability Study Of Lunsekimig Compared With Placebo In Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized By An Eosinophilic Phenotype
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
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.
Participation to the study consists of 3 periods:
* Screening period of up to 4 weeks
* Randomized intervention period of approximately 48 weeks
* Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
Print study details
Site IRB:
25-006385NCT ID:
NCT07190209Sponsor Protocol Number:
EFC18243/PERSEPHONE
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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
A Study To Assess The Safety, Tolerability, And Pharmacokinetics Of ABSK-011 In Patients With Advanced Solid Tumor
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 an open-label phase 1 study with an escalation part and an expansion part.
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 |
Print study details
Site IRB:
25-012948NCT ID:
NCT04906434Sponsor Protocol Number:
ABSK-011-101
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Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN
A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
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 primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
| Mayo Clinic Location |
Status |
Contact |
Albert Lea, MN
| Open for enrollment | View complete study & contact information |
Scottsdale/Phoenix, AZ
| Open for enrollment |
Eau Claire, WI
| Open for enrollment |
Jacksonville, FL
| Open for enrollment |
La Crosse, WI
| Open for enrollment |
Mankato, MN
| Open for enrollment |
Rochester, MN
| Open for enrollment |
Print study details
Site IRB:
24-012591NCT ID:
NCT06492616Sponsor Protocol Number:
STML-ELA-0422
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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
Sacituzumab Tirumotecan (MK-2870) In Combination With Pembrolizumab Versus Pembrolizumab Alone In Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
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 primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
Print study details
Site IRB:
25-000876NCT ID:
NCT06170788Sponsor Protocol Number:
2870-007
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Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN
MC230818 Understanding The Mechanisms Of Clonal And Non-clonal Cytopenia Following CAR-T Therapy
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
This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene mutations may help identify the risk of cytopenia in patients with multiple myeloma or CD19 positive LPD following CAR-T therapy.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
| Mayo Clinic Location |
Status |
Contact |
Albert Lea, MN
| Contact us for the latest status | View complete study & contact information |
Scottsdale/Phoenix, AZ
| Contact us for the latest status |
Eau Claire, WI
| Contact us for the latest status |
Jacksonville, FL
| Contact us for the latest status |
La Crosse, WI
| Contact us for the latest status |
Mankato, MN
| Contact us for the latest status |
Rochester, MN
| Contact us for the latest status |
Print study details
Site IRB:
24-005734NCT ID:
NCT06630104Sponsor Protocol Number:
MC230818
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Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Rochester, MN
Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
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
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
| Mayo Clinic Location |
Status |
Contact |
Eau Claire, WI
| Closed for enrollment | View complete study & contact information |
Jacksonville, FL
| Closed for enrollment |
La Crosse, WI
| Closed for enrollment |
Rochester, MN
| Closed for enrollment |
Print study details
Site IRB:
24-001909NCT ID:
NCT05710328Sponsor Protocol Number:
EA1211
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Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
Study Of Magrolimab Combination Therapy To Treat Unresectable, Locally Advanced Or Metastatic Triple-Negative 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
The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment
The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination with sacituzumab govitecan as
determined by confirmed objective response rate (ORR) by investigator assessment
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
Print study details
Site IRB:
21-008934NCT ID:
NCT04958785Sponsor Protocol Number:
GS-US-586-6144