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ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer

Targeted TherapyOncology
  • The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
  • Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
  • ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

NCT02441946CompletedPhase 2
Eli Lilly and Company
Posted 8/1/2015

Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

NCT04551495Active, Not RecruitingPhase 2
Jules Bordet Institute
Posted 1/14/2021

First European Patients Receive Accelerator-Based Boron Neutron Capture Therapy for Head and Neck Cancer

Targeted TherapyOncology
  • Helsinki University Hospital and Neutron Therapeutics have treated the first European patients with accelerator-based boron neutron capture therapy (BNCT), marking the first clinical application outside of Asia.
  • BNCT is a targeted radiation therapy that uses epithermal neutrons to activate boron compounds in tumor cells, delivering precise treatment in just one or two sessions while sparing healthy tissue.
  • The milestone treatment is part of a ten-patient clinical trial for locally recurrent head and neck cancer using Neutron Therapeutics' nuBeam® system, with plans to expand availability throughout Europe and the United States.

Alectinib Plus Bevacizumab Shows Promising Results in First-Line Treatment of ALK-Positive NSCLC

Precision MedicineOncologyTargeted Therapy
  • The ALEK-B phase 2 trial demonstrated that combining alectinib with bevacizumab significantly improved progression-free survival in ALK-positive NSCLC patients, with 97% remaining progression-free at 12 months and 64% at 36 months.
  • The combination therapy showed remarkable efficacy in preventing CNS progression, with a 36-month intracranial progression-free survival rate of 87.8% and only 8.8% cumulative incidence of new brain metastases.
  • Despite higher rates of adverse events compared to alectinib monotherapy, particularly proteinuria (70.7%) leading to bevacizumab discontinuation in 43.9% of patients, the treatment maintained quality of life improvements throughout the study period.

Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

NCT03779191CompletedPhase 2
Instituto Nacional de Cancerologia de Mexico
Posted 4/8/2020

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

NCT05200481Active, Not RecruitingPhase 2
Intergroupe Francophone de Cancerologie Thoracique
Posted 5/18/2022

Avacta's pre|CISION Technology Makes Toxic Chemotherapy Safer and More Effective

Targeted TherapyOncology
  • Avacta has developed a novel "masked" chemotherapy approach called pre|CISION that dramatically improves safety profiles of toxic cancer drugs while maintaining therapeutic efficacy.
  • The technology works by rendering chemotherapy inactive in normal tissues and only activating the drug when it reaches the tumor microenvironment, significantly reducing systemic toxicity.
  • Clinical applications of pre|CISION technology could potentially transform cancer treatment by allowing higher dosing of potent chemotherapeutics and expanding treatment options for patients who cannot tolerate conventional chemotherapy.

China Approves Xuanyuening (Bireociclib): First Dual-Indication CDK Inhibitor for Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • China's NMPA has approved Xuanzhu Biopharm's Bireociclib (Xuanyuening®), a novel multi-target CDK inhibitor for HR+/HER2- advanced breast cancer with dual indications.
  • The drug can be used in combination with fulvestrant after endocrine therapy failure and is the only CDK4/6 inhibitor approved in China as monotherapy for heavily pretreated patients.
  • Clinical trials showed impressive efficacy with median PFS of 17.5 months in combination therapy and 11 months as monotherapy, addressing specific needs of Chinese breast cancer patients.

A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

NCT05077449Active, Not RecruitingPhase 3
Xuanzhu Biopharmaceutical Co., Ltd.
Posted 11/16/2021

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

NCT04539496Unknown StatusPhase 1
Sihuan Pharmaceutical Holdings Group Ltd.
Posted 5/22/2018

Narmafotinib Combination Shows Superior Response in Pancreatic Cancer ACCENT Trial

Targeted TherapyOncology
  • Amplia Therapeutics' Phase 1b/2a ACCENT trial has recorded 15 confirmed partial responses in pancreatic cancer patients receiving narmafotinib combined with standard chemotherapy.
  • The trial results demonstrate that adding narmafotinib, a highly selective FAK inhibitor, to gemcitabine and Abraxane chemotherapy is superior to chemotherapy alone in advanced pancreatic cancer.
  • With 21 of 55 enrolled patients still on study, researchers anticipate additional partial responses may be observed before final data readout expected in mid-Q3 2025.

ACCENT: AMP945 in Combination with Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer

NCT05355298Active, Not RecruitingPhase 1
Amplia Therapeutics Limited
Posted 5/31/2022

Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression

OncologyTargeted TherapyDrug Approval
  • The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
  • All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
  • The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

NCT02099058Active, Not RecruitingPhase 1
AbbVie
Posted 1/15/2014

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial

OncologyTargeted Therapy
  • A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses.
  • At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment.
  • The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.

Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma

NCT03770416CompletedPhase 2
M.D. Anderson Cancer Center
Posted 2/15/2019

Exosomes Emerge as Dual-Purpose Tools in Cancer: From Drug Resistance Mechanisms to Therapeutic Delivery Systems

Targeted Therapy
  • Exosomes, nano-sized vesicles secreted by cells, play crucial roles in gastrointestinal cancer drug resistance by transferring oncogenic molecules between cancer cells and their microenvironment, with over 4.8 million GI cancer cases worldwide highlighting the urgent need for resistance-overcoming strategies.
  • Tumor-derived exosomes (TDEs) demonstrate significant therapeutic potential as drug delivery vehicles, offering superior biocompatibility and targeting ability compared to synthetic nanoparticles, while also serving as promising biomarkers for cancer diagnosis through liquid biopsy approaches.
  • Advanced microfluidic technologies are revolutionizing exosome isolation and detection methods, enabling more precise characterization of exosomal contents for both diagnostic applications and therapeutic targeting in cancer treatment.

Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue

NCT01294072RecruitingNot Applicable
University of Louisville
Posted 1/1/2011

A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From EIther Primary Gastric Cancer or Colorectal Cancer (CRC)

NCT05375604TerminatedPhase 1
Codiak BioSciences
Posted 6/28/2022

Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

NCT05334849Completed
Lin Chen
Posted 11/1/2018

Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

NCT02393703Recruiting
Memorial Sloan Kettering Cancer Center
Posted 3/1/2015

Pancreatic Cancer Detection Consortium

NCT06388967Recruiting
City of Hope Medical Center
Posted 3/15/2023

SiVEC's BactPac Platform: Engineered Bacteria Redefining Targeted Drug Delivery for Cancer and Beyond

OncologyTargeted Therapy
  • SiVEC Biotechnologies has developed BactPac, an innovative platform using engineered non-pathogenic bacteria to both produce and deliver therapeutic biologics with precise cellular targeting capabilities.
  • The company's lead asset, SVC-KRAb, delivers circular mRNA to produce nanobodies targeting mutant RAS proteins, reducing tumor volume by over 80% in preclinical studies with clinical trials expected in Q3 2026.
  • BactPac offers significant advantages over conventional delivery systems, including targeted delivery to difficult-to-reach tissues, immune evasion enabling repeat dosing, and simplified manufacturing through bacterial fermentation processes.

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