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Clinical Trial News

UGN-102 Shows Promise as Non-Surgical Option for Low-Grade Bladder Cancer

  • UGN-102 met primary endpoints in Phase 3 ATLAS and ENVISION trials for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
  • The ATLAS trial demonstrated a 55% reduction in the risk of recurrence, progression, or death compared to TURBT alone, with similar complete response rates.
  • In the ENVISION trial, UGN-102 achieved a 79.2% complete response rate at 3 months, suggesting potential as a primary chemoablative therapy.
  • UroGen Pharma plans to submit a new drug application (NDA) to the FDA in 2024, pending further positive data on duration of response.

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT04688931TerminatedPhase 3
UroGen Pharma Ltd.
Posted 2/19/2021

Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

NCT04387461Unknown StatusPhase 2
CG Oncology, Inc.
Posted 12/8/2020

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

NCT02625961Active, Not RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 2/10/2016

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT05243550Active, Not RecruitingPhase 3
UroGen Pharma Ltd.
Posted 3/1/2022

Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

NCT00109655Unknown StatusPhase 1
Cell Genesys
Posted 4/1/2005

Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

NCT02365818CompletedPhase 2
CG Oncology, Inc.
Posted 6/2/2015

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

NCT04452591Active, Not RecruitingPhase 3
CG Oncology, Inc.
Posted 10/27/2020

Targeting the Endothelin A Receptor in IgA Nephropathy: A New Therapeutic Approach

Recent advancements in the treatment of IgA Nephropathy (IgAN) focus on targeting the Endothelin-A receptor (ETAR) to mitigate renal deterioration. This approach is based on the understanding that ETAR activation contributes to various pathophysiological effects in the kidney, including vasoconstriction, inflammation, and fibrosis. Clinical trials have shown that ETAR blockade can reduce proteinuria and slow disease progression, offering a promising new avenue for IgAN treatment.

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

NCT05003986RecruitingPhase 2
Travere Therapeutics, Inc.
Posted 8/12/2021

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

NCT03762850Active, Not RecruitingPhase 3
Travere Therapeutics, Inc.
Posted 12/11/2018

NEPTUNE Match Study

NCT04571658Enrolling by Invitation
University of Michigan
Posted 3/1/2021

Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

NCT04724837CompletedPhase 2
AstraZeneca
Posted 4/28/2021

Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

NCT05834738Active, Not RecruitingPhase 2
Novartis Pharmaceuticals
Posted 7/20/2023

Atrasentan in Patients With Proteinuric Glomerular Diseases

NCT04573920Active, Not RecruitingPhase 2
Novartis Pharmaceuticals
Posted 3/15/2021

A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

NCT04663204Active, Not RecruitingPhase 2
University of Leicester
Posted 12/10/2020

Atrasentan in Patients With IgA Nephropathy

NCT04573478Active, Not RecruitingPhase 3
Chinook Therapeutics, Inc.
Posted 12/11/2020

CAGE Bio's Topical Tofacitinib Shows Promise in Phase 2 Atopic Dermatitis Trial

  • CAGE Bio's CGB-500, a topical formulation of 1% tofacitinib, demonstrated a 98% reduction in EASI scores compared to 28% with the vehicle in atopic dermatitis patients.
  • The Phase 2 study achieved all primary and secondary endpoints, with 95% of patients in the active group achieving treatment success versus 24% in the vehicle group.
  • CGB-500 was well-tolerated, with no treatment-emergent adverse events, suggesting a favorable safety profile for localized treatment of immuno-dermatological disorders.
  • CAGE Bio plans to initiate dose ranging and registration trials to further validate the efficacy and safety of CGB-500 for regulatory submissions and potential approval.

Elraglusib Receives FDA Orphan Drug Designation for Pancreatic Cancer Treatment

  • The FDA has granted Orphan Drug Designation to elraglusib, a GSK-3β inhibitor, for the treatment of patients with pancreatic cancer, addressing a high unmet medical need.
  • Elraglusib is currently being evaluated in phase 2 trials, both as a monotherapy and in combination with other agents like gemcitabine and nab-paclitaxel, for advanced pancreatic cancer.
  • The Orphan Drug Designation provides Actuate Therapeutics with benefits including assistance in drug development, tax credits, and potential marketing exclusivity.
  • Elraglusib targets molecular pathways involved in tumor growth and resistance to chemotherapy, showing promise as a novel therapeutic approach for pancreatic cancer.

9-ING-41 in Patients with Advanced Cancers

NCT03678883Active, Not RecruitingPhase 2
Actuate Therapeutics Inc.
Posted 1/4/2019

9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma

NCT05239182TerminatedPhase 2
Anwaar Saeed
Posted 1/26/2022

FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer

NCT05077800RecruitingPhase 2
Colin D. Weekes, M.D., PhD
Posted 3/21/2022

Transcranial Random Noise Stimulation Shows Promise in Pediatric ADHD

  • A clinical trial found that transcranial random noise stimulation (tRNS) combined with cognitive training may alleviate ADHD symptoms in children.
  • 55% of parents reported significant clinical improvement in their children's ADHD symptoms after tRNS treatment, compared to 17% in the placebo group.
  • The study, involving 23 children aged 6-12, suggests tRNS has the potential to become a new therapeutic option for ADHD.
  • Researchers are planning a larger clinical trial, with hopes of FDA approval for tRNS as a medical device for ADHD treatment.

TYRA Biosciences Receives FDA Orphan Drug Designation for TYRA-300 in Achondroplasia

• TYRA Biosciences received FDA Orphan Drug Designation for TYRA-300, an oral FGFR3 selective inhibitor, for treating achondroplasia, the most common form of dwarfism. • TYRA-300 aims to address not only height but also long-term health complications like cranial and spinal stenosis associated with achondroplasia. • A Phase 2 clinical study of TYRA-300 in pediatric achondroplasia is planned for 2024, following positive preclinical results and an upcoming IND submission. • Michael Bober, M.D. Ph.D., a specialist in skeletal dysplasia, has been appointed VP, Clinical Development and Medical Affairs, to lead the TYRA-300 program.

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

NCT05544552RecruitingPhase 1
Tyra Biosciences, Inc
Posted 11/22/2022

AI Cancer Detection Tool Shows 13% Boost in Prostate Cancer Diagnosis, Expands to Breast Cancer Screening in Wales

• The Welsh NHS has reported a 13% increase in prostate cancer detection using the IBEX Galen AI platform during initial pilot studies at Betsi Cadwaladr Health Board.
• The successful AI diagnostic tool will be expanded to five additional health boards across Wales and extended to include breast cancer screening applications.
• The implementation is part of Wales' new digital health strategy, prioritizing AI-powered diagnostics to improve early detection and streamline cancer diagnosis workflows.

Advancements in HCC Treatment: The Role of TACE Combined with Targeted and Immune Therapies

Recent studies highlight the effectiveness of combining Transarterial Chemoembolization (TACE) with molecularly targeted agents and immune checkpoint inhibitors (ICIs) for treating intermediate and advanced Hepatocellular Carcinoma (HCC). This combination therapy shows promising results in improving overall survival (OS) and progression-free survival (PFS) compared to TACE combined with molecularly targeted agents alone. The research underscores the potential of this triple therapy in enhancing the prognosis of HCC patients, despite the need for further investigation into optimal treatment intervals and criteria.

NIH Launches Clinical Trials to Evaluate Long COVID Treatments

• The NIH has initiated clinical trials under the RECOVER initiative to assess potential treatments for long COVID symptoms, addressing a significant unmet medical need. • The RECOVER-VITAL trial will investigate the efficacy of Paxlovid in treating persistent SARS-CoV-2, while RECOVER-NEURO will explore interventions for cognitive dysfunction, including brain fog. • Additional trials, RECOVER-SLEEP and RECOVER-AUTONOMIC, will address sleep disturbances and autonomic nervous system dysfunction, respectively, with plans for an exercise and fatigue study. • These trials represent a crucial step in the comprehensive effort to understand, treat, and prevent long COVID, with the aim of informing clinical care and improving patient outcomes.

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