Fluorescence-guided surgical Phase I/IIa clinical trials “A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery” with pHLIP® ICG imaging agent are in progress at the Memorial Sloan Kettering Cancer Center in partnership with Stryker Corp. The phase I is successfully completed. The Phase IIa is in progress. The purpose of this study is to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely, and to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and. The ClinicalTrials.gov identifier is NCT05130801, https://clinicaltrials.gov/ct2/show/NCT05130801
Therapeutic Phase I clinical trial “Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors” with CBX-12 is successfully completed. CBX-12 is alphalex™-exatecan, where alphalex™ consists of a pHLIP® peptide and linker is a lead therapeutic candidate of Cybrexa Therapeutics (pHLIP, Inc sublicensee). This was a first-in-human, Phase I open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors. The ClinicalTrials.gov identifier is NCT04902872, https://clinicaltrials.gov/study/NCT04902872.
Therapeutic Phase II clinical trial “A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer” with CBX-12 is in progress. CBX-12 is alphalex™-exatecan, where alphalex™ consists of a pHLIP® peptide and linker is a lead therapeutic candidate of Cybrexa Therapeutics (pHLIP, Inc sublicensee). The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days. The ClinicalTrials.gov identifier is NCT06315491, https://clinicaltrials.gov/study/NCT06315491.
Therapeutic Phase I clinical trial “Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers” with CBX-12 is in progress sponsored by National Cancer Institute (NCI). CBX-12 is alphalex™-exatecan, where alphalex™ consists of a pHLIP® peptide and linker is a lead therapeutic candidate of Cybrexa Therapeutics (pHLIP, Inc sublicensee). This phase I trial studies how well CBX-12 works in treating patients with solid tumors that have spread from where they first started (primary site) to started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or other places in the body (metastatic). This trial is being done to find out if this approach is better or worse than the usual approach for advanced cancers. The ClinicalTrials.gov identifier is NCT05691517, https://clinicaltrials.gov/study/NCT05691517
PET imaging Phase I clinical trial “Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer” with pHLIP® 18F imaging agent is completed at the Memorial Sloan Kettering Cancer Center. The purpose of the study was to measure the safety of the investigational imaging agent, pHLIP® 18F or 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave. The ClinicalTrials.gov identifier is NCT04054986, https://clinicaltrials.gov/study/NCT04054986