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Clinical Trial

Metabolic kinetic phenotyping to predict cachexia and health outcomes in response to chemoradiation in patients with Head & Neck Cancer

Fifteen patients with advanced H&N cancer who will receive chemoradiation therapy as first line treatment will be studied (as weight loss is expected). The cancer patients will be recruited at the UT Health Mays Cancer Center (MCC) in San Antonio with testing to be performed at the Barshop Institute. The cancer group will be compared to 15 control subjects, recruited at CTRAL (Center for Translational Research on Aging and Longevity) in College Station, who are age/sex/BMI matched and with no active or historic cancer diagnosis based on extensive medical screening.

Clinical Trial

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Po

This is a Phase 3 open-label, active-control, 2:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as ‘the investigational arm’) vs pembrolizumab alone (referred to as ‘the control arm’) in immune checkpoint inhibitor (ICI) naïve subjects with first line unresectable recurrent and/or metastatic (R/M) HPV16-positive HNSCC with a CPS ≥ 1.

Clinical Trial

A Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered via Intraventricular Catheter for Any Primary Solid Tumor Cancer with Lep

This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses.

Clinical Trial

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid Tumors

Dose-Escalation Part (Part 1)Primary Objectives:•To assess the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumorsBackfill Part (Part 2)Primary Objectives:•To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumorsDose-Expansion Part (Part 3)Primary Objectives:•To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma•To determine the recommended phase 2 dose (RP2D) of YL217