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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
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

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

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study

Rochester, MN
- See Details
Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study
- 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:
  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 phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows pertuzumab and trastuzumab to be given by injection under the skin and shortens their administration time compared to pertuzumab or trastuzumab alone. Chemotherapy drugs, such as enzalutamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide may kill more cancer cells.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

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Site IRB:
Rochester, Minnesota: 21-013057

NCT ID:
NCT05730712

Sponsor Protocol Number:
MC210504

XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

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

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XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

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:
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 investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

Print study details

Site IRB:
- Rochester, Minnesota: 22-003002
- Jacksonville, Florida: 22-003002
- Scottsdale/Phoenix, Arizona: 22-003002
NCT ID:
NCT05005728
Sponsor Protocol Number:
XmAb20717-04

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Jacksonville, FL
- See Details
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
- Location:
  Observational
  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

The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.

The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.

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

Print study details
Site IRB:
Jacksonville, Florida: 21-007137

NCT ID:
NCT03151629

Sponsor Protocol Number:
IRONMAN
Understanding Financial Toxicity in Management of Advanced Prostate Cancer from Qualitative Approach

Rochester, MN
- See Details
Understanding Financial Toxicity in Management of Advanced Prostate Cancer from Qualitative Approach
- Location:
  Observational
  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

The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.

This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
Rochester, Minnesota: 22-005013

Sponsor Protocol Number:
22-005013

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Search Results 1-5 of 5 for

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study

XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Understanding Financial Toxicity in Management of Advanced Prostate Cancer from Qualitative Approach

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