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Clinical Trial News

Keymed's Stapokibart Receives Approval in China for Atopic Dermatitis

  • Keymed Biosciences' Stapokibart (Kangyueda) has been approved by China's NMPA for treating moderate-to-severe atopic dermatitis in adults.
  • The approval was based on a Phase III trial where Stapokibart demonstrated significant improvements in EASI-75 and IGA scores at week 16.
  • Long-term treatment with Stapokibart showed sustained clinical benefits and a favorable safety profile over 52 weeks.
  • Stapokibart is the first domestically manufactured IL-4Rα antibody drug approved in China, blocking both IL-4 and IL-13 signaling.

NKGen Biotech's Troculeucel Shows Promise in Early Alzheimer's Trial, Advances to Phase 2

  • NKGen Biotech's troculeucel, an autologous NK cell therapy, demonstrated cognitive improvement in moderate Alzheimer's patients in a Phase 1 trial.
  • Two of three patients treated with the highest dose of troculeucel showed improvement on the CDR-SB scale, moving from moderate to mild Alzheimer's.
  • The Phase 2 trial, a randomized, double-blind, placebo-controlled study, has dosed its first patient and will evaluate troculeucel in a larger cohort.
  • Troculeucel is being developed for neurodegenerative disorders and cancers, representing a potential new treatment option for Alzheimer's disease.

Moberg Pharma's MOB-015 Phase 3 Trial Faces Uncertainty After Subgroup Analysis

  • Moberg Pharma reports lower than expected clinical cure rates in a subset of patients from its ongoing North American Phase 3 trial of MOB-015 for onychomycosis.
  • The Phase 3 study, conducted across 33 centers in the US and Canada with 384 patients, is crucial for potential US registration and commercialization of MOB-015.
  • The company emphasizes data integrity and awaits topline results before speculating on the future potential of MOB-015, a topical terbinafine formulation.
  • Moberg Pharma will host a conference call to discuss the implications of these findings with its CEO, CMO, and CSO.

World Sepsis Day Highlights Critical Need for Better Trial Design and Targeted Therapeutics

• Sepsis claims 11 million lives globally each year, with over 7,000 facilities participating in World Sepsis Day to raise awareness and promote medical education.
• Current sepsis treatments focus on antibiotics and supportive care, but there remains a critical lack of drugs targeting underlying pathophysiological processes.
• Recent Phase III trial failures, including AM Pharma's reCAP and Asahi Kasei's thrombomodulin alfa, highlight the need for improved trial design and AI-driven patient stratification.

International Research Team Proposes Multimodal Treatment Strategy for Long COVID and Post-Acute Infectious Syndromes

  • An international research team has developed a comprehensive treatment approach combining pharmacological and physical therapies for post-acute infectious syndromes, including long COVID.
  • Metformin and low-dose naltrexone showed promising results in treating long COVID symptoms, with metformin demonstrating reduced diagnosis rates in a double-blind trial.
  • The multimodal strategy includes physical interventions like extracorporeal apheresis, which improved symptoms in 70% of long COVID patients in clinical studies.

Hong Kong Approves Two New Drugs for Hypercalcemia Under "1+" Mechanism

  • Hong Kong approves two new oral drugs for treating hypercalcemia in patients with parathyroid carcinoma and primary hyperparathyroidism under the "1+" mechanism.
  • The "1+" mechanism, implemented since November 2023, expedites the registration of drugs for life-threatening or severely debilitating diseases.
  • These drugs, already approved in Japan, met Hong Kong's safety, efficacy, and quality standards after local expert review of clinical data.
  • Since implementing the "1+" mechanism, the Department of Health has received over 250 enquiries involving more than 70 pharmaceutical companies.

Increased Antimicrobial Use Precedes B-Cell Cancer Diagnosis by Up to a Decade, Danish Study Reveals

  • A comprehensive Danish study of over 48,000 patients reveals significantly elevated antimicrobial use in multiple B-cell cancer types, particularly CLL, MM, MZL, and LPL, up to 10 years before diagnosis.
  • Researchers identified three distinct patterns of infection risk, with some cancers showing gradual immune system deterioration over a decade, while others like follicular lymphoma displayed normal antimicrobial use until just before diagnosis.
  • The study found penicillins and macrolides were the most commonly prescribed antimicrobials, with chronic lymphocytic leukemia patients showing increased use of both macrolides and antivirals for over a decade pre-diagnosis.

AI and Behavioral Data to Predict Mental Health Treatment Outcomes in Young Adults

  • Mount Sinai and IBM Research are collaborating on the PREDiCTOR study to predict mental health treatment outcomes using AI and behavioral data.
  • The study will analyze clinical interviews, smartphone data, and cognitive testing to identify patterns indicative of treatment discontinuation and hospitalization.
  • Researchers aim to develop objective, scalable clinical signatures for personalized prediction and decision-making in treating mental health disorders in 15-30 year olds.
  • The $20 million NIMH-funded study will track diverse patients across six outpatient clinics, focusing on early intervention during a critical developmental window.

Personalized, Less Toxic Therapies Advance Treatment for HER2-Positive Breast Cancer

  • De-escalation strategies in early-stage HER2-positive breast cancer, such as the APT and ATEMPT trials, show high rates of invasive disease-free survival with less toxic regimens.
  • The TRAIN-2 trial demonstrated that omitting anthracycline from treatment in stage II and III HER2-positive breast cancer does not compromise efficacy and reduces cardiotoxicity.
  • Ongoing trials like ATEMPT 2.0 and CompassHER2 RD are exploring personalized treatments to address specific challenges, including central nervous system (CNS) recurrences.
  • Combination therapies and novel agents like T-DXd and tucatinib are improving outcomes in metastatic settings, with focus on overcoming resistance and preventing CNS disease.

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

NCT00542451CompletedPhase 2
Dana-Farber Cancer Institute
Posted 10/1/2007

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

NCT00021255CompletedPhase 3
Sanofi
Posted 4/1/2001

ATEMPT 2.0: Adjuvant T-DM1 vs TH

NCT04893109RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 6/16/2021

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NCT01808573CompletedPhase 3
Puma Biotechnology, Inc.
Posted 3/29/2013

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/9/2018

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

STOP-HER2: Stopping Trastuzumab in HER2+ MBC

NCT05721248Active, Not RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 4/19/2023

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

NCT00567190CompletedPhase 3
Genentech, Inc.
Posted 2/12/2008

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

NCT04266249Active, Not RecruitingPhase 2
ECOG-ACRIN Cancer Research Group
Posted 3/13/2020

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

NCT01853748Active, Not RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2013

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

NCT04622319Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/4/2020

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

NCT00878709CompletedPhase 3
Puma Biotechnology, Inc.
Posted 7/9/2009

T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

NCT04457596RecruitingPhase 3
Alliance for Clinical Trials in Oncology
Posted 3/2/2021

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

NCT01996267Active, Not RecruitingPhase 3
The Netherlands Cancer Institute
Posted 12/1/2013

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

NCT01772472CompletedNot Applicable
Hoffmann-La Roche
Posted 4/3/2013

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

NCT02492711CompletedPhase 3
MacroGenics
Posted 8/24/2015

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study

NCT03820063Active, Not RecruitingPhase 2
Borstkanker Onderzoek Groep
Posted 2/27/2019

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

NCT02614794CompletedPhase 2
Seagen Inc.
Posted 1/28/2016

Eisai's E7820 Shows Promise in Shrinking Tumors with HRR Deficiency

  • Eisai's E7820 demonstrated tumor shrinkage in patient-derived xenograft models of bile duct and uterine cancers, suggesting potential efficacy in these tumor types.
  • Mutations in homologous recombination repair (HRR) genes like BRCA1, BRCA2, and ATM were identified as potential predictive biomarkers for E7820 response.
  • A Phase I investigator-initiated clinical study has been launched to evaluate the safety and efficacy of E7820 in Japanese patients with solid tumors.
  • The study leverages the National Cancer Center’s J-PDX library to accelerate anticancer drug development for rare and refractory cancers.

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