Norton Shores, Wisconsin

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

This study consists of 2 parts: Part A and Part B. Part A: Participants who did not participate in either parent study (TAK-279-3001 [NCT06088043] or TAK-279-3002 [NCT06108544]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B. Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043) or TAK-279-3002 (NCT06108544) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

The phase 1a Dose Escalation portion of the trial will enroll subjects with platinum-resistant/refractory ovarian cancer (PRROC), testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once weekly (Q1W) for each cycle. A cycle is defined as 28 days. Subjects will be dosed until documentation of disease progression, unacceptable toxicity, or subject/physician decision. The phase 1b dose expansion phase will evaluate CTIM-76 in one indication (PRROC, endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each dose level). This is to enable dose- and exposure-response analyses. Dosing will follow the same schedule as Phase 1a. A priming dose will be administered on Day 1, and the full cohort dose will be administered weekly thereafter. Expansion doses for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a. The selection of the recommended Phase 2 dose (RP2D) will be based on the totality of data from Phase 1b.

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

This open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose expansion study involves STX-001 administration, alone or in combination with pembrolizumab, to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Phase 1 consists of 4 planned dose escalation cohorts of STX-001 delivered as a monotherapy (Cohorts 1m), and 4 planned dose escalation cohorts of STX-001 delivered as a combination therapy, with pembrolizumab treatment given concurrently (Cohorts 1c). New patients will be enrolled in each dose escalation cohort. Phase 2 consists of dose expansion cohorts in patients with 2 defined cancer types: triple-negative breast cancer (TNBC) and melanoma. Phase 2 will evaluate STX-001 in combination with pembrolizumab; the recommended Phase 2 dose (RP2D) will be selected based on analysis of the totality of data from Phase 1.

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer

The study will be started with a dose escalation part of ABSK112 administered in repeated 28-day cycles in patients with NSCLC. The expansion part of oral ABSK112 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with locally advanced or metastatic NSCLC harboring EGFR Exon20ins.

PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma

Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled brain metastasis. The study will have three phases, Phase 1, Phase 2a and Phase 2b. Phase 1 is a standard cohort dose escalation 3+3 design with a modified Fibonacci dose escalation used to determine the maximum tolerated dose to select a recommended Phase 2 dose (RP2D) of NEO212 for Phase 2a and Phase 2b. The initial dose of NEO212 will be 170 mg and the dose will increase in successive cohorts (220, 400, 610, 810, and 1,000 mg) until a MTD is reached and a RP2D is selected. There will be up to 42 patients enrolled in Phase 1. In the event two DLTs are experienced in any cohort, a dose de- escalation cohort will be followed (with half of the dose increase from the previous cohort) to determine the MTD/RP2D. Phase 2a is a safety run-in study with a standard 3+3 design used to confirm the safety of the MTD/RP2D of NEO212 when given in combination with select SOC regimens (as defined in Appendix 1) for patients with uncontrolled metastases to the brain (see Appendix 2). There will be up to 12 patients enrolled into each combination regimen to confirm safety. One dose below the NEO212 MTD/RP2D Cohort Dose will be administered as a starting dose to establish safety (3+3), before moving to Phase 2b with the MTD/RP2D (3+3). In the event that two DLTs are experienced for patients receiving the MTD/RP2D in combination with SOC, the dose de-escalation cohort will be expanded to determine the MTD for a newly established Phase 2b Treatment Group. Phase 2b is a dose expansion study to assess efficacy of NEO212 alone, at the MTD/RP2D in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype as a single Treatment Group. A second Treatment Group to study the MTD/RP2D of NEO212 in combination with select SOC regimens in patients with solid tumors and uncontrolled metastases to the brain established in Phase 2a will be evaluated. Phase 2b will be initiated for patients with Astrocytoma IDH-mutant or Glioblastoma IDH-wildtype alongside Phase 2a. There will be up to 28 patients enrolled to have 27 evaluable patients enrolled in each Phase 2b Treatment Group. For all phases of the study, NEO212 will be self-administered daily for days 1-5 of a 28- day treatment cycle.

A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

The main questions this clinical trial aims to answer are: - What, if any, are the side effects of different dose levels in humans? - What is the maximum tolerated dose? - How does the human body process the drug? - Does the drug slow, stop or eliminate cancer in human participants? Participants will be asked to: - provide informed consent - be evaluated by physicians and provide laboratory specimens to determine if eligible - take MBQ-167 orally twice a day for at least 21 days - may continue dosing, if safe to do so, until not effective or other decision to stop is made - participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug

Study of INBRX-109 in Conventional Chondrosarcoma

This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles

Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.