Wentworthville

Researchers are evaluating PEP08, a new oral cancer therapy, in a first-in-human clinical trial for patients with advanced or metastatic solid tumors that have a specific genetic change called MTAP deletion. This Phase 1a/1b study aims to assess the safety, how the body processes the drug, and early signs of anti-tumor activity. It seeks to find the maximum tolerated dose and the recommended dose for future studies, both when PEP08 is given alone and combined with other treatments. Participants will receive PEP08 either by itself or with another anti-cancer agent depending on the study phase. The study has three parts: Part 1 is currently open and focuses on increasing doses of PEP08 alone to find safe levels. Future parts will include an extension of monotherapy and combination therapy with other treatments. Treatments are given orally, and dosing will be carefully monitored throughout the study. During the study, participants will attend regular clinic visits for treatment administration, lab tests, and tumor assessments using imaging. Researchers will monitor for adverse events and dose-limiting toxicities up to 21 days and track safety outcomes for up to two years. The study will also evaluate preliminary effectiveness by checking tumor responses and tolerability. Participants must be adults with measurable tumors and meet specific health and safety requirements to join.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating the safety and effectiveness of selinexor as a maintenance treatment for patients with p53 wild-type endometrial carcinoma who have responded to platinum-based chemotherapy. This phase 3 trial will enroll 276 adults who have achieved either a partial or complete response after at least 12 weeks of treatment. The goal is to understand if selinexor can help prevent cancer from progressing in these patients. Participants will be randomly assigned to receive either selinexor tablets or matching placebo tablets by mouth. Selinexor is given as 60 mg doses, consisting of three 20 mg tablets. Treatment will begin 3 to 8 weeks after completing platinum chemotherapy. This is a double-blind study, meaning neither the participants nor the researchers will know who receives selinexor or placebo during the trial. During the study, participants will be regularly assessed for disease progression using standardized criteria called RECIST v1.1. Investigators will monitor progression-free survival from the time of randomization until either disease worsens or death occurs, up to 34 months. Participants will also have evaluations to check their health status and organ function throughout the trial to ensure safety and treatment adherence.