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  • A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating The Safety And Tolerability Of Intravenous KK2269 Monotherapy And Combination Therapy With Docetaxel In Adult Participants With Solid Tumors Scottsdale/Phoenix, AZ Jacksonville, FL This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269. In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies. In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.
  • A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, And Pharmacokinetic Study Of Q901 Administered Via Intravenous Infusion In Adult Patients With Selected Advanced Solid Tumors With A Cohort Expansion At The Recommended Phase 2 Dose Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

    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.

  • Obesity And Inflammation Impact Immunotherapy Outcomes In Renal Cancer Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the extent to which immunotherapy failure in kidney cancer patients with obesity is associated with prolonged, body-wide inflammation. Hypothesis: In patients with obesity, high sustained inflammation will be associated with poor immunotherapy outcomes, high inflammation that resolves during therapy will be associated with better outcomes, and sustained low inflammation will be associated with the best therapy outcomes. These general trends will also hold true for non-obese RCC patients, although the magnitude of the response rates may be shifted.

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