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  • A Multicenter FIH Dose Escalation And Optimization Phase I/IIa Trial To Investigate Safety, Tolerability, PK, And Efficacy Of The 5T4 ADC TUB-030 In Patients With Advanced Solid Tumors (5-STAR 1-01) Rochester, Minn. The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
  • A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of PF-08052666/SGN-MesoC2 in Participants With Advanced Solid Tumors Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz. This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called SGN-MesoC2. SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will have 3 parts. Part A and Part B of the study will find out how much SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if SGN-MesoC2 is safe and if it works to treat solid tumor cancers.
  • A Phase 1, First In Human, Dose-Escalation Study Of TORL-1-23 In Participants With Advanced Cancer Rochester, Minn. This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
  • A Phase 1/1b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer Jacksonville, Fla., Rochester, Minn.

    The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.

  • Catalina-2: A Phase 2 Study Evaluating The Efficacy And Safety Of TORL-1-23 In Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal And Fallopian Tube Cancers) Expressing Claudin 6 (CATALINA-2) Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz. A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
  • MC210601 Phase II Clinical Trial of PLX038 in Patients with Platinum-resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancer Rochester, Minn.

    The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.

  • Single-Arm Phase II Study Of Carboplatin And Mirvetuximab Soravtansine In First-Line Treatment Of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube Or Primary Peritoneal Cancer Who Are Folate Receptor Α Positive Rochester, Minn. The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors.

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