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Triple-Tracer PET Imaging Reveals High Intrapatient Heterogeneity in Metastatic Prostate Cancer

  • A multi-center study using triple-tracer PET imaging (18F-FDG, 68Ga-PSMA, 68Ga-DOTATATE) reveals high intrapatient intermetastatic heterogeneity (IIH) in mCRPC patients.
  • IIH was observed in 82.7% of patients, with 45.9% showing at least one 18F-FDG-positive/68Ga-PSMA-negative lesion, suggesting potential neuroendocrine differentiation.
  • Patients with IIH exhibited significantly shorter overall survival (9.5 months) compared to those without IIH, highlighting the clinical impact of tumor heterogeneity.
  • Based on imaging criteria, 53.1% of participants were eligible for PSMA-targeted radiopharmaceutical therapy, emphasizing the role of PET imaging in treatment stratification.

3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer

NCT04000776Completed
Université de Sherbrooke
Posted 12/16/2019

Vivani Medical's GLP-1 Implant for Obesity and Overweight Approved for Human Trials in Australia

  • Vivani Medical received approval to begin its first-in-human clinical trial in Australia for its subdermal GLP-1 implant, NPM-115, designed for obesity and overweight individuals.
  • The LIBERATE-1 trial will assess the safety, tolerability, and pharmacokinetics of the exenatide implant, utilizing Vivani's NanoPortal technology for extended drug delivery.
  • The trial includes a comparison against weekly semaglutide injections, aiming to demonstrate comparable efficacy to drugs like Ozempic and Wegovy with twice-yearly administration.
  • Vivani anticipates initiating the trial in late 2024, with initial data expected in 2025, potentially supporting regulatory submissions in the U.S. and other regions.

Belantamab Mafodotin Plus VRd Shows Promising Efficacy in Newly Diagnosed Multiple Myeloma

  • The GEM-BELA-VRD trial showed a 94% objective response rate with belantamab mafodotin plus VRd in transplant-eligible, newly diagnosed multiple myeloma patients.
  • Complete response rates improved over time, reaching 82% after one year of maintenance therapy, with minimal residual disease negativity in 91.2% of patients.
  • Progression-free survival rates were 90% at 12 months and 85% at 24 months, with similar outcomes in high-risk and standard-risk cytogenetic groups.
  • Ocular adverse events were common but manageable with dose adjustments, and the combination demonstrated an encouraging safety profile overall.

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT03544281CompletedPhase 1
GlaxoSmithKline
Posted 9/20/2018

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

NCT03525678CompletedPhase 2
GlaxoSmithKline
Posted 6/18/2018

Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients

NCT04802356RecruitingPhase 2
PETHEMA Foundation
Posted 4/7/2021

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT04162210Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 4/2/2020

Darolutamide sNDA Submitted to FDA and EMA for mHSPC Treatment

  • Bayer has submitted applications to the FDA and EMA for darolutamide, seeking approval for use in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC).
  • The submissions are based on Phase III ARANOTE trial results, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT.
  • Darolutamide, already approved for other prostate cancer indications, could offer a new treatment option for mHSPC patients, regardless of chemotherapy use.
  • The ARANOTE trial showed a favorable safety profile for darolutamide plus ADT, with consistent benefits across secondary endpoints.

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

NCT04736199Active, Not RecruitingPhase 3
Bayer
Posted 2/23/2021

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

NCT05794906RecruitingPhase 3
Bayer
Posted 4/3/2023

Cyclacel Completes Enrollment in Fadraciclib Trial for Tumors with CDKN2A/B Abnormalities

  • Cyclacel Pharmaceuticals completed enrollment in Cohort 8 of its Phase 2 trial of fadraciclib, a CDK2/9 inhibitor, focusing on patients with advanced solid tumors and lymphoma exhibiting CDKN2A/B abnormalities.
  • The rapid enrollment, completed in approximately six months, highlights the significant unmet need for cancer patients with these specific genetic aberrations.
  • Early data from the trial shows promising signs of stable disease and tumor shrinkage in a squamous cell cancer patient with CDKN2A abnormalities after treatment with oral fadraciclib.
  • Updated safety and efficacy data from the trial will be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in October.

Enanta's EDP-323 Shows Strong Efficacy in RSV Human Challenge Trial

  • Enanta Pharmaceuticals' EDP-323 demonstrated significant viral load reduction in a Phase 2a human challenge trial for Respiratory Syncytial Virus (RSV).
  • The study showed an 85-87% reduction in viral load and a 97-98% reduction in infectious viral load compared to placebo.
  • EDP-323 also significantly reduced total clinical symptoms by 66-78% and was generally safe and well-tolerated in healthy adults.
  • These results support EDP-323's potential as a once-daily oral treatment for RSV, with further data to be presented at a future conference.

Ohh-Med's Vertica Device Offers Drug-Free Solution for Erectile Dysfunction

  • Ohh-Med's Vertica device uses radio frequency technology to stimulate collagen production in the penis, improving blood flow and erection quality.
  • Clinical data shows Vertica has an over 85% success rate in treating ED, with positive results seen within 1-3 weeks of use, and no reported side effects.
  • Vertica is approved for use in Australia, the EU, Israel, and the UK, and is currently undergoing trials in the US for FDA approval.
  • The device offers a drug-free alternative to medications like Viagra, which can have side effects and may not be effective for all men.

Placebo Use in IBD Trials Linked to Increased Risk of Adverse Outcomes

  • Systematic reviews reveal that patients with IBD receiving placebo in clinical trials face a higher risk of worsening disease activity compared to those on active treatment.
  • Placebo groups also showed a significantly greater likelihood of experiencing serious adverse events and venous thromboembolism, highlighting potential harms.
  • Researchers suggest alternative trial designs to minimize placebo exposure, such as platform studies or Bayesian analysis, for future IBD drug development.
  • Experts emphasize the need for transparent communication with patients about the potential consequences of participating in placebo-controlled IBD studies.

Genentech's Gazyva Demonstrates Efficacy in Phase 3 Lupus Nephritis Trial

  • Genentech's Gazyva, combined with standard therapy, achieved a statistically significant complete renal response in lupus nephritis patients at 76 weeks.
  • The Phase 3 REGENCY study results support Gazyva's potential as a new treatment option for lupus nephritis, addressing a critical unmet need.
  • Gazyva is under investigation for other autoimmune conditions, including membranous nephropathy and childhood-onset nephrotic syndrome.
  • Genentech is sharing the REGENCY trial data with regulatory agencies to expedite Gazyva's availability for lupus nephritis patients.

FDA Lifts Clinical Hold on Biomea Fusion's Diabetes Trials of BMF-219

  • The FDA lifted the clinical hold on Biomea Fusion's trials of BMF-219 for type 1 and type 2 diabetes after safety review.
  • The hold was initiated due to potential drug-induced hepatotoxicity, but no serious liver injury was confirmed in the Phase 2b expansion study.
  • The FDA suggested trial modifications, including a lower starting dose of 100mg and increased liver enzyme monitoring.
  • Biomea Fusion anticipates topline data from Phase IIa of COVALENT-112 and Phase IIb of COVALENT-111 in Q4 2024.

Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)

NCT05731544CompletedPhase 1
Biomea Fusion Inc.
Posted 8/17/2022

Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer

NCT05631574TerminatedPhase 1
Biomea Fusion Inc.
Posted 1/12/2023

Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL

NCT05153330TerminatedPhase 1
Biomea Fusion Inc.
Posted 1/24/2022

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

NCT06152042TerminatedPhase 2
Biomea Fusion Inc.
Posted 12/28/2023

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