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A Comprehensive Translational Research Platform for Colorectal Cancer (CRC Platform)
Rochester, Minn.
The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or prognostic biomarkers.
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A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (ARC-25)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.
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A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors
Rochester, Minn.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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A Phase I Trial of Sonidegib and Pembrolizumab in Advanced Solid Tumors
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
Closed for Enrollment
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(ECTx) ZL-1201-001; First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer
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A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EVIDENCE OF ANTI-TUMOR ACTIVITY OF PF-07284892 (ARRY-558) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
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A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high.
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A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
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A Phase 2 Clinical Trial Investigating Oncolytic Immunotherapy in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With Advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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A Phase I Trial of Sonidegib and Pembrolizumab in Advanced Solid Tumors
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
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CV202-103: A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
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EA2174, A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma
Rochester, Minn.
The purpose of this study is to anayze the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
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MC200404 Phase Ib Open-label Study to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of Multiple Subcutaneous Injections of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to TAS-102 in Late-stage Metastatic Colorectal Cancer Subjects (OBERTO-201) (OBERTO-201)
Rochester, Minn.
The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.
PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.
Participants will receive TAS-102 and PolyPEPI1018 which in combination is investigational and isn’t approved by the U.S. Food and Drug Administration (FDA). However, TAS-102 is FDA approved for treatment of metastatic colorectal cancer. The FDA has allowed the use of this combination in this research study.
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Oberto-301, Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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