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Clinical Trial News

Greenwich LifeSciences Expands Breast Cancer Immunotherapy Trial to Italy

• Greenwich LifeSciences partners with Gruppo Italiano Mammella (GIM) to expand its Phase III FLAMINGO-01 trial in Italy. • Nine top Italian institutions will participate in evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence. • In 2022, Italy reported 58,160 new breast cancer cases, highlighting the critical need for improved treatments and preventative strategies. • Patient enrollment has commenced at Italian sites, with Professor Grazia Arpino leading as the Italian National Principal Investigator.

Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

NCT05232916RecruitingPhase 3
Greenwich LifeSciences, Inc.
Posted 8/11/2022

Nivolumab Plus AVD Improves Outcomes in Advanced Hodgkin Lymphoma

  • A Phase III trial showed that nivolumab plus AVD significantly improved progression-free survival in patients with advanced-stage classic Hodgkin lymphoma compared to brentuximab vedotin plus AVD.
  • The two-year progression-free survival rate was 92% in the nivolumab plus AVD group versus 83% in the brentuximab vedotin plus AVD group, with fewer immune-related adverse events.
  • MRI can predict recurrence risk in rectal cancer patients post-chemoradiation, with clinical complete response correlating with higher organ preservation rates.
  • Adherence to American dietary guidelines may reduce the risk of prostate cancer grade reclassification in men undergoing active surveillance for grade group 1 disease.

Ziftomenib Shows Promise in Treatment of Relapsed/Refractory AML

  • Ziftomenib, a selective menin inhibitor, demonstrates promising clinical activity in relapsed/refractory AML patients, especially those with NPM1 mutations or KMT2A rearrangements.
  • The KOMET-001 trial revealed a 25% complete remission rate in patients with KMT2A rearrangement or NPM1 mutations at the 600 mg dose, with a 35% complete remission rate in NPM1 mutated patients.
  • Ziftomenib exhibits a manageable safety profile, with the most common severe adverse events including anemia, febrile neutropenia, and pneumonia, and a low incidence of MEN1 mutation development.
  • Ongoing clinical studies are exploring ziftomenib in combination with other therapies, such as 7+3 induction chemotherapy and azacytidine/venetoclax, to enhance its effectiveness in AML treatment.

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

NCT04067336RecruitingPhase 1
Kura Oncology, Inc.
Posted 9/12/2019

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML

NCT05735184RecruitingPhase 1
Kura Oncology, Inc.
Posted 7/18/2023

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399RecruitingPhase 1
Syndax Pharmaceuticals
Posted 11/5/2019

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

NCT05453903RecruitingPhase 1
Janssen Research & Development, LLC
Posted 10/4/2022

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML)

NCT06852222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/4/2025

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

NCT02993523Active, Not RecruitingPhase 3
AbbVie
Posted 2/2/2017

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

NCT03013998RecruitingPhase 1
Beat AML, LLC
Posted 11/1/2016

Delta-Fly Pharma's DFP-14323 Phase III Trial Progresses with Afatinib Recommendation

  • Delta-Fly Pharma's Phase III trial of DFP-14323 in combination with Afatinib for NSCLC is ongoing, targeting EGFR mutation-positive uncommon mutations.
  • Afatinib received a strong recommendation as a first-line treatment for EGFR mutation-positive NSCLC in Japan's Lung Cancer Treatment Guidelines 2024.
  • The Phase III trial is a superiority study comparing DFP-14323 plus Afatinib to Afatinib alone, with progression-free survival as the primary endpoint.
  • DFP-14323, an oral CD13/APN receptor inhibitor, aims to improve outcomes for NSCLC patients, including those with cancer stem cells.

Physiotherapy Shows Promise in Managing Myopia Progression in Children

  • A retrospective study evaluated the effectiveness of physiotherapy in treating and preventing the progression of uncomplicated acquired myopia in children aged 6 to 11 years.
  • The study found that physiotherapeutic methods significantly reduced the annual myopia progression rate compared to single vision spectacle lenses over a two-year period.
  • Electropuncture, low-intensity laser stimulation, and optical-reflex treatment were among the physiotherapeutic methods applied, showing notable efficacy.
  • The benefits of physiotherapy were most pronounced in children with moderate myopia and no family history of the condition, highlighting personalized treatment approaches.

Cetuximab Shows Superior Efficacy Over Durvalumab in Cisplatin-Intolerant Head and Neck Cancer Patients

  • A clinical trial revealed that cetuximab is more effective than durvalumab in treating head and neck cancers for patients who cannot tolerate cisplatin.
  • The study found a significantly higher probability of being alive and disease-free at two years with cetuximab compared to durvalumab (64% vs. 51%).
  • The trial was halted early to allow all participants to switch to cetuximab due to its clear benefits, reinforcing its role as a strong alternative to cisplatin.
  • Cetuximab's effectiveness was consistent regardless of HPV infection status, suggesting broad applicability in this patient population.

Machine Learning Identifies Serological Predictors of COVID-19 Outcomes

  • A study of hospitalized and non-hospitalized COVID-19 patients used machine learning to identify key serological markers associated with disease severity.
  • Higher levels of binding antibodies, complement activation, and ACE2 inhibition were correlated with reduced risk of intubation or death.
  • Random forest models demonstrated that serological data, combined with demographics, improved prediction of COVID-19 outcomes.
  • The findings offer insights into immune responses and potential targets for therapeutic interventions in severe COVID-19 cases.

Palazestrant Plus Ribociclib Shows Promise in Advanced Breast Cancer

• Palazestrant combined with ribociclib demonstrates encouraging clinical activity in ER+/HER2- advanced or metastatic breast cancer patients, including those with ESR1 mutations. • The combination therapy shows a favorable safety profile, consistent with ribociclib, and is well-tolerated, supporting its potential as a first-line treatment option. • Interim Phase 1b/2 data reveals a 73% 6-month progression-free survival rate across all patients, with median PFS not yet reached after a 12-month follow-up. • Olema Oncology plans to initiate a pivotal Phase 3 trial (OPERA-02) of palazestrant with ribociclib as a first-line treatment based on these promising results.

ImCheck's ICT01 Shows Promise in Treating AML in Older, Unfit Patients

• ImCheck Therapeutics' ICT01, combined with azacitidine and venetoclax, demonstrates high complete remission rates in newly diagnosed AML patients. • The EVICTION trial's interim results highlight ICT01's safety and tolerability in older or unfit AML patients, including those with TP53 mutations. • ICT01, a novel γ9δ2 T-cell activator, targets butyrophilin 3A, enhancing anti-tumor immune responses in hematologic malignancies. • The Phase I/II study's findings will be presented at the 66th American Society of Hematology Annual Meeting, offering insights into ICT01's potential.

First-in-Human Study of ICT01 in Patients With Advanced Cancer

NCT04243499Active, Not RecruitingPhase 1
ImCheck Therapeutics
Posted 2/10/2020

Shilpa Medicare Gains Approval for Phase III Clinical Trials of Recombinant Human Albumin 20%

  • Shilpa Medicare has received approval from the Subject Expert Committee (Haematology) to proceed with Phase III clinical trials for its Recombinant Human Albumin (rHA) 20%.
  • The rHA 20%, derived from yeast, provides a purified alternative to human serum albumin, addressing the limited supply of the latter due to reliance on blood or plasma donations.
  • Albumin is crucial in various medical treatments, including blood volume restoration, fluid replacement in burn injuries, and support during surgeries, highlighting rHA's potential impact.
  • Shilpa Medicare is the first Indian company to receive approval for Phase III clinical trials of recombinant human albumin, marking a significant milestone.

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