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A Phase 2, Open-Label, Randomized, Master Protocol Study To Evaluate Safety And Efficacy Of Multiple Treatment Combinations With Telisotuzumab Adizutecan In Subjects With Metastatic Colorectal Cancer
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Closed for Enrollment
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A Multicenter, Open-label Phase 2 Study To Evaluate The Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Patients With Selected Solid Tumors
Scottsdale/Phoenix, Ariz.
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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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 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
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
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 2, Randomized Study To Evaluate Safety, Efficacy, And Optimal Dose Of ABBV-400 In Combination With Fluorouracil, Folinic Acid, And Bevacizumab In Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.
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A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
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A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, And Pharmacodynamic Study Of Oral TP 1454
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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An Open-label, Multicenter, Phase 1a/1b Study Of IGM-8444 As A Single Agent And In Combination In Subjects With Relapsed, Refractory, Or Newly Diagnosed Cancers
Scottsdale/Phoenix, Ariz.
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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C4221015 An Open-label, Multi-center, Randomized Phase 3 Study Of First-line Encorafenib Plus Cetuximab With Or Without Chemotherapy Vs. Standard-of-Care Therapy With A Safety Lead-in Of Encorafenib And Cetuximab Plus Chemotherapy In Participants With Metastatic BRAF V600E-mutant Colorectal Cancer
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
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MicroOrganosphereTM (MOS) Drug Screen To Lead Care (MODEL) Precision Oncology Pilot Trial In Colorectal Cancer (CRC)
Jacksonville, Fla.,
Rochester, Minn.,
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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Ph.1, Open-Label, Dose Escalation & Expansion For Safety, Tolerability, PK, & Anti-Tumor Activity Of STP707 Administered IV In Subjects With Advanced/Metastatic Or Surgically Unresectable Solid Tumors Who Are Refractory To Standard Therapy.
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
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