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Clinical Trial News

Eisai's Foscenvivint Shows Promise in Pancreatic Cancer Development Pipeline

  • Eisai is advancing the development of Foscenvivint for pancreatic cancer treatment, expanding their oncology portfolio beyond established drugs like Lenvima and Halaven.
  • The pharmaceutical company's global presence, with research facilities across Japan, US, and UK, positions them strongly to conduct comprehensive clinical development of Foscenvivint.
  • Eisai's track record in successful drug development, including LEQEMBI for Alzheimer's and Lenvima for endometrial carcinoma, suggests promising potential for Foscenvivint's approval pathway.

Alfasigma Advances Filgotinib Maleate Development for IgG4-Related Disease Treatment

• Alfasigma is developing filgotinib maleate as a potential therapeutic option for Immunoglobulin G4-Related Disease (IgG4-RD), expanding treatment possibilities for this rare inflammatory condition.
• The drug candidate demonstrates broad therapeutic potential, being investigated across multiple autoimmune conditions including Sjögren's syndrome, psoriatic arthritis, and Crohn's disease.
• Alfasigma, headquartered in Bologna, Italy, leverages its global presence across 15 countries to advance filgotinib maleate's development program.

IMUNON's IMNN-001 Shows Promise in Advanced Ovarian Cancer Treatment

  • IMUNON will host an Ovarian Cancer R&D Day on September 18, 2024, featuring updates on IMNN-001, an investigational therapy for ovarian cancer.
  • Phase 2 OVATION 2 study data showed IMNN-001 treatment was associated with an 11.1-month increase in median overall survival in advanced ovarian cancer patients.
  • The R&D Day will include presentations from experts discussing the clinical significance of OVATION 2 results and the potential role of IMNN-001 in treatment.
  • IMUNON executives will outline the next steps for IMNN-001's development program, including plans for a Phase 3 registration study.

HR20013 Shows Non-Inferiority in Preventing Chemotherapy-Induced Nausea and Vomiting

  • A recent study, HR20013, has demonstrated non-inferiority compared to standard antiemetic therapy in preventing chemotherapy-induced nausea and vomiting (CINV).
  • The PROFIT study assessed the efficacy and safety of HR20013, providing evidence for its potential as an alternative treatment option for CINV.
  • The findings suggest that HR20013 could offer a comparable level of protection against CINV, potentially expanding the available options for patients undergoing chemotherapy.
  • Further research may explore HR20013's specific advantages or suitability for certain patient subgroups experiencing CINV.

Lecanemab Shows Promise in Slowing Cognitive Decline in Early Alzheimer's Disease

• Lecanemab, trialed at HMRI, effectively removes amyloid from the brain, potentially preventing Alzheimer's and slowing cognitive decline. • The drug slowed mental decline by 25% in individuals with mild dementia, marking it as a potentially effective treatment. • The clinical trial involved screening participants aged 65-80 for amyloid accumulation, followed by bi-weekly infusions of Lecanemab or a placebo. • Lecanemab is under consideration for approval by the Therapeutic Goods Administration (TGA) in Australia, with potential approval expected by the end of 2024.

ASC22 and Chidamide Combination Shows Promise in Reducing HIV Reservoir Size

  • A Phase II clinical trial evaluated the combination of ASC22, an anti-PD-L1 antibody, and chidamide, a histone deacetylase inhibitor, in HIV-infected adults on ART.
  • The study demonstrated a reduction in total and integrated HIV DNA in PBMCs, suggesting a decrease in the HIV reservoir size after 12 weeks of treatment.
  • The combination therapy also led to improvements in HIV-specific CD8+ T cell function, indicating enhanced immune control of HIV.
  • The treatment was generally well-tolerated, with adverse events monitored throughout the study period.

Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide in HIV-infected Patients With Antiviral Suppression

NCT05129189RecruitingPhase 2
Shanghai Public Health Clinical Center
Posted 6/29/2022

MacroGenics' Vobramitamab Duocarmazine Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • MacroGenics announced Phase 2 data for vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC) at ESMO 2024.
  • The TAMARACK trial evaluated vobra duo, an antibody-drug conjugate targeting B7-H3, in mCRPC patients.
  • Updated safety and efficacy data, including the primary endpoint of 6-month radiographic progression-free survival (rPFS), were presented.
  • MacroGenics will host a conference call on September 16, 2024, to discuss the TAMARACK poster data and provide a corporate update.

Durvalumab Combinations Show Promise in Resectable NSCLC and High-Risk Breast Cancer

• In resectable NSCLC, adding datopotamab deruxtecan to durvalumab and chemotherapy led to a 34.1% pathologic complete response rate, exceeding historical benchmarks. • The Neo-CheckRay trial showed that adding durvalumab to neoadjuvant chemotherapy and SBRT doubled pathologic complete response rates in high-risk, HR-positive breast cancer. • Both studies demonstrated manageable safety profiles, supporting further investigation of these novel combinations in larger, randomized controlled trials.

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

Nadunolimab Shows Promise in Patients with Cancer Progression After PD-1 Inhibitor Therapy

  • New data from two clinical trials reveal nadunolimab's potential in patients who have progressed on pembrolizumab treatment, a key immunotherapy.
  • The CANFOUR trial showed a 72% objective response rate in second-line NSCLC patients treated with nadunolimab plus chemotherapy after pembrolizumab failure.
  • CIRIFOUR trial data indicated a median survival of 19.7 months and a 60% disease control rate with nadunolimab and pembrolizumab in heavily pretreated patients.
  • Both studies suggest nadunolimab targets immunosuppressive cells within the tumor microenvironment, offering a new approach for overcoming immunotherapy resistance.

Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer.

NCT05181462Active, Not RecruitingPhase 1
Cantargia AB
Posted 1/11/2022

A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

NCT04990037CompletedPhase 1
Cantargia AB
Posted 7/19/2021

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

NCT03267316CompletedPhase 1
Cantargia AB
Posted 9/19/2017

A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

NCT04452214CompletedPhase 1
Cantargia AB
Posted 9/24/2020

A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors

NCT05116891CompletedPhase 1
Cantargia AB
Posted 9/22/2021

Ultimovacs' UV1 Shows Promise in Mesothelioma Subgroup Analysis at ESMO 2024

  • Ultimovacs presented updated data from the Phase II NIPU trial of UV1 in combination with ipilimumab and nivolumab for mesothelioma at ESMO 2024.
  • The epithelioid subgroup, representing 70% of mesothelioma patients, showed a median PFS improvement of 5.5 months with UV1 combination therapy compared to 2.9 months with immunotherapy alone.
  • While the primary endpoint was not met, secondary endpoint analysis revealed a positive overall survival difference with UV1 treatment at the latest follow-up.
  • Ultimovacs plans to discuss these findings with key stakeholders to determine potential next steps for UV1 in addressing the unmet needs of mesothelioma patients.

Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

NCT04300244Active, Not RecruitingPhase 2
Åslaug Helland
Posted 5/4/2020

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