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Clinical Trial News

FDA Advisory Committee Recommends Narrowing Sulopenem's Indication for UTI Treatment

• FDA advisory committee suggests limiting sulopenem's use to patients with specific complicated urinary tract infections (cUTIs) where alternative treatments are limited. • The Antimicrobial Drugs Advisory Committee voted that the benefits of sulopenem outweigh the risks, but only for a restricted patient population. • Concerns were raised regarding the drug's broad-spectrum activity and potential for promoting antimicrobial resistance, influencing the committee's recommendation. • Iterum Therapeutics faces the challenge of aligning the drug's label with the FDA's requirements following the advisory committee's guidance.

Expert Challenges 'Benign' Classification of Gleason 6 Prostate Cancer, Emphasizes Need for Comprehensive Assessment

  • Leading oncologist Dr. Anthony D'Amico from Harvard Medical School warns against labeling all Gleason 6 prostate cancers as "benign," highlighting the heterogeneous nature of these tumors.
  • Multiple clinical factors beyond Gleason score, including PSA kinetics, tumor volume, and perineural invasion, should guide treatment decisions for localized prostate cancer patients.
  • Comprehensive patient assessment is crucial for determining optimal management strategies, ranging from active surveillance to definitive therapy, to ensure appropriate treatment intensity.

Datopotamab Deruxtecan Fails to Meet Overall Survival Endpoint in TROPION-Breast01 Trial

• AstraZeneca's Datopotamab Deruxtecan (Dato-DXd) did not achieve statistical significance in overall survival for metastatic breast cancer patients. • The Phase III TROPION-Breast01 trial included patients with HR-positive, HER2-low or negative breast cancer previously treated with endocrine therapy. • While the trial met its primary endpoint of progression-free survival, the final overall survival analysis was not statistically significant. • Further analysis and discussions with regulatory authorities are planned to determine future steps for Dato-DXd in breast cancer treatment.

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

NCT05629585Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/28/2022

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

NCT05104866Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/18/2021

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864RecruitingPhase 3
AstraZeneca
Posted 11/23/2023

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

NCT05374512Active, Not RecruitingPhase 3
AstraZeneca
Posted 5/16/2022

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

NCT06112379RecruitingPhase 3
AstraZeneca
Posted 11/14/2023

Study Links Testosterone to Heightened COVID-19 Severity in Men Through Immune Response Modulation

  • A groundbreaking Nature study reveals testosterone's role in regulating immune response to COVID-19, potentially explaining higher mortality rates among men despite similar infection rates.
  • Research tracking 23 trans men undergoing hormone therapy demonstrates testosterone's impact on immune signaling systems, specifically type-1 interferon and tumor necrosis factor pathways.
  • Findings suggest testosterone may trigger severe inflammatory responses like cytokine storms in COVID-19 patients, offering new insights for targeted therapeutic approaches.

FDA Approves AirPods Pro 2 as Over-the-Counter Hearing Aids

  • The FDA has authorized Apple's AirPods Pro 2 as over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss.
  • A software update will enable the AirPods Pro 2 to amplify sounds and customize hearing profiles based on user's hearing test results.
  • Clinical studies showed that users experienced similar benefits from the AirPods Pro 2 as from professionally fitted hearing aids.
  • This approval aims to increase accessibility and reduce the stigma associated with hearing aids, impacting over 30 million Americans.

Dimerix's First Patient Completes Phase 3 Trial and Enters DMX-200 Open Label Extension Study for Kidney Disease

  • Dimerix has enrolled the first patient into the Open Label Extension (OLE) study for its kidney disease drug candidate DMX-200 after completing the ACTION3 Phase 3 clinical trial.
  • The OLE study allows patients who have successfully completed the ACTION3 Phase 3 clinical trial to start or continue a two-year treatment of DMX-200 in an unblinded setting.
  • The OLE study will collect additional long-term data, such as safety and tolerability, to support future potential regulatory filings for DMX-200.
  • Interim analysis showed DMX-200 outperformed placebo in reducing proteinuria, with the Independent Data Monitoring Committee affirming no safety concerns.

OSE Immunotherapeutics Launches Phase 3 Trial of Tedopi® for Second-Line NSCLC

  • OSE Immunotherapeutics initiates the Artemia Phase 3 trial to evaluate Tedopi® in second-line metastatic non-small cell lung cancer (NSCLC).
  • The global trial will enroll 363 HLA-A2 positive patients with secondary resistance to immune checkpoint inhibitors across multiple countries.
  • Tedopi® monotherapy will be compared to standard of care, with overall survival as the primary endpoint for regulatory registration.
  • Trial in Progress posters were presented at the 2024 World Conference on Lung Cancer and will be presented at the European Society for Medical Oncology congress.

FDA Approves Gene Therapies Casgevy and Lyfgenia for Sickle Cell Disease

  • The FDA has approved Casgevy (Vertex Pharmaceuticals) and Lyfgenia (Bluebird Bio) as novel gene therapies for sickle cell disease, offering potential long-term solutions.
  • Casgevy utilizes CRISPR/Cas9 technology to reactivate fetal hemoglobin production, while Lyfgenia employs a viral vector to introduce a functional hemoglobin gene.
  • Clinical trials showed Casgevy significantly reduced vaso-occlusive crises in patients, and Lyfgenia led to a substantial number of patients being transfusion-free.
  • These gene therapies require stem cell harvesting, modification, and re-infusion, involving chemotherapy and close monitoring, representing a significant advancement in treating this genetic condition.

Advancements in HER2-Mutant NSCLC Therapies: A Pipeline Overview

  • Several companies are actively developing novel therapies for HER2-mutant non-small cell lung cancer (NSCLC), indicating a robust pipeline.
  • Key players like AstraZeneca and Dizal Pharmaceuticals are advancing treatments such as Trastuzumab deruxtecan and DZD-9008 through clinical trials.
  • Clinical trials are evaluating the efficacy and safety of various therapeutic approaches, including tyrosine kinase inhibitors and antibody-drug conjugates.
  • These emerging therapies aim to address unmet needs in HER2-mutant NSCLC, offering potential improvements in treatment outcomes.

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer

NCT03863223Active, Not RecruitingPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 4/22/2019

A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

NCT03980054Unknown StatusPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 7/12/2019

Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy

NCT04447118Active, Not RecruitingPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 9/11/2020

HS-20093 Shows Promise in Pretreated Extensive-Stage Small Cell Lung Cancer

• HS-20093, a B7-H3-targeted antibody-drug conjugate, demonstrated encouraging antitumor activity in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). • In the ARTEMIS-001 trial, HS-20093 achieved an overall response rate (ORR) of 61.3% at 8 mg/kg and 50.0% at 10 mg/kg in ES-SCLC patients. • The disease control rate (DCR) was high in both cohorts, with 80.6% for the 8.0-mg/kg group and 95.5% for the 10.0-mg/kg group, indicating effective disease stabilization. • The safety profile of HS-20093 was manageable, with hematologic adverse events being the most common, and the 8.0-mg/kg dose showing a better safety profile.

ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

NCT05276609RecruitingPhase 1
Shanghai Hansoh Biomedical Co., Ltd
Posted 11/28/2021

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