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A Dose-Escalation And Expansion Study Of The Safety And Efficacy Of XL092 In Combination With Immuno-Oncology Agents In Subjects With Unresectable Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
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A Phase 1, Open-Label, Multicenter Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
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A Phase III Study Of Cabazitaxel With Or Without Carboplatin In Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC), Stratified By Aggressive Variant Signature
Scottsdale/Phoenix, AZ
Jacksonville, FL
La Crosse, WI
The purpose of this study compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.
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A Randomized, Open-Label, Phase 2/3 Study Of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During Or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
Closed for Enrollment
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A Phase III Study Of Cabazitaxel With Or Without Carboplatin In Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC), Stratified By Aggressive Variant Signature
Mankato, MN
The purpose of this study compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.
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MC240508: Prospective Genomic Surveillance Of Bladder Cancer Using Tissue And Blood Based Whole Genome Sequencing Technologies
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to monitor molecular residual disease (MRD) through a tumor-informed WGS-based ctDNA approach developed by Veracyte.
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