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A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCSZ11 as a Monotherapy and in Combination in Patients with Advanced or Metastatic Solid Tumors
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy in patients with advanced or metastatic solid tumors.
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A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an anti-LILRB2 / PD-L1 bispecific antibody SPX- 303 in Patients with Solid Tumors (SPX-303)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered via Intravenous Infusion as Monotherapy and Combination Therapies in Adult Patients with Selected Advanced Solid Tumors with Cohort Expansions at the Recommended Phase 2 Dose (QRNT-009)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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.
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A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors (SGNCEA5C-001)
Scottsdale/Phoenix, Ariz.
The puprose of the study is to test the safety of SGN-CEACAM5C in participants with Advanced solid tumors.
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Closed for Enrollment
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2015-013-00US1: A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Advanced Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
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849-010 A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy (KRYSTAL-12)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
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A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer (FRESCO-2)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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A Phase 1b Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors (MT-5111)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate dose escalation and expansion of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors.
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A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Detection of Recurrent Colorectal Cancer by Assay of Novel Methylated DNA Markers in Plasma: Prospective Phase I Cohort Study
Rochester, Minn.,
Jacksonville, Fla.
The primary aims for this study:
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To select an optimal panel of novel MDMs for detection of recurrent or metastatic CRC and to assess MDM panel accuracy (sensitivity & specificity) for this application.
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To evaluate the ability of the plasma MDM assay to predict CRC recurrence when tested serially following curative resection of CRC metastases.
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MicroOrganosphereTM (MOS) Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
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Patient-derived Organoid as a New Personalized Tool for Colorectal Cancer Peritoneal Disease Treatment
Rochester, Minn.
The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.
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TROV-054 A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS Mutation
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
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