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A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)
The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men = 45 years ... -
Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition
A dose-escalation phase (phase I) is added to determine RP2D. In phase I, 3 mg/kg dose were added in the dose escalation phase, including ... -
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1) -
Site for A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY TOLERABILITY IMMUNOGENICITY AND IMMUNOPERSISTENCE OF A CLOSTRIDIOIDES DIFFICILE VACCINE ADMINISTERED IN A 2-DOSE REGIMEN WITH NOVEL ADJUVANTS IN HEALTHY ADULTS
This Phase 1/2 study in adults greater than 65 years of age will evaluate the safety and immunogenicity of Clostridioides (formerly Clostridium) difficile vaccine ... -
A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic product (LBP)containing a fixed ... -
A Phase I/II Study of TheraT Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
From sponsor: As background, this protocol started as a Phase I Dose Escalation and is now a Phase I/II Escalation/Expansion. This protocol has ... -
A Phase 1/2a Multicenter Open-Label First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors
This is a multicenter, non-randomized, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at ... -
PHASE I/II STUDY LADARIXIN AND SOTORASIB IN ADVANCED KRAS G12C MUTANT NON-SMALL CELL LUNG CANCER (NSCLC).
This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in subjects with advanced KRAS G12C mutant NSCLC. -
AN OPEN-LABEL MULTICENTER PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AB-2100 IN PATIENTS WITH RECURRENT ADVANCED OR METASTATIC CLEAR-CELL RENAL CELL CARCINOMA (CCRCC)
This is an open-label, multicenter Phase 1/2 study evaluating the safety, efficacy, cellular kinetics, immunogenicity, and pharmacodynamics of AB-2100 in adult subjects with recurrent ... -
A Phase 1/2 Multi-Center Open-Label Study to Evaluate the Safety Tolerability and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors
TNG908 is a potent and selective oral small molecule inhibitor of PRMT5 that binds cooperatively with MTA to inhibit PRMT5 function. Elevated levels of MTA ...