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Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Scottsdale/Phoenix, AZ
- See Details
Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
- Location:
  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 determine the safety and tolerability of OBT076, and to define the maximum tolerated dose (MTD) and/or the RP2D of OBT076.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Open for enrollment
View complete study & contact information

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Site IRB:
Scottsdale/Phoenix, Arizona: 21-006633

NCT ID:
NCT04064359

Sponsor Protocol Number:
OBT076-001

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

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

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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Location:
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 part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.

The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, an expansion phase at the established RP2D will be undertaken in participants with selected advanced solid tumors. In Part 2 Cohort 2, a safety run in and expansion phase will be undertaken with Q901 at the RP2D administered in combination with pembrolizumab (400 mg Q6W) in participants with advanced solid tumors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information
Rochester, Minn.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Jacksonville, Florida: 22-009877
- Rochester, Minnesota: 22-009877
- Scottsdale/Phoenix, Arizona: 22-009877
NCT ID:
NCT05394103
Sponsor Protocol Number:
QRNT-009

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Albert Lea, MN, La Crosse, WI, Mankato, MN

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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Location:
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 this study is to evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
La Crosse, Wis.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment
Scottsdale/Phoenix, Ariz.	Closed for enrollment
Albert Lea, Minn.	Open for enrollment
Mankato, Minn.	Open for enrollment

Print study details

Site IRB:
- La Crosse, Wisconsin: 21-009845
- Jacksonville, Florida: 21-009845
- Scottsdale/Phoenix, Arizona: 21-009845
- Albert Lea, Minnesota: 21-009845
- Mankato, Minnesota: 21-009845
NCT ID:
NCT04852887
Sponsor Protocol Number:
NRG-BR007

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Search Results 1-9 of 9 for

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Eliminating Breast Cancer Surgery in Exceptional Responders with Neoadjuvant Systemic Therapy

Breast MR

A Registry for the Collection and Maintenance of Biological Specimens for Breast Cancer Research

A Study to Evaluate Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)

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