MedPath

Clinical Trial News

C4 Therapeutics' CFT1946 Shows Promise in BRAF V600 Mutant Solid Tumors

• C4 Therapeutics presented Phase 1 data for CFT1946, a BRAF V600 degrader, at ESMO 2024, showing a well-tolerated safety profile in patients with advanced solid tumors. • Early data suggests CFT1946 demonstrates dose-dependent bioavailability and successfully degrades BRAF V600E protein, indicating proof of mechanism. • Initial anti-tumor activity was observed, with some patients achieving partial responses and tumor reductions across various BRAF V600 mutation types. • The Phase 1 trial continues with expansion cohorts exploring monotherapy and combination approaches, with additional data expected in 2025.

A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors

NCT05668585Active, Not RecruitingPhase 1
C4 Therapeutics, Inc.
Posted 12/8/2022

Summit's Ivonescimab Demonstrates Superiority Over Keytruda in Lung Cancer Trial

  • Summit Therapeutics' ivonescimab significantly reduced the risk of lung cancer progression by 49% compared to Merck's Keytruda in a Phase 3 trial.
  • The bispecific antibody, ivonescimab, extended median progression-free survival to 11.1 months versus 5.8 months with Keytruda.
  • The HARMONi-2 trial, conducted in China, showed consistent benefits across various patient subgroups, including those with low and high PD-L1 expression.
  • While ivonescimab showed promising results, further studies, including multi-regional trials, are needed to confirm its efficacy and safety in diverse populations.

HARMONi-3

2024-513087-26-00RecruitingPhase 3
Summit Therapeutics Inc.

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

Osimertinib and Amivantamab Gain FDA Approval for EGFR-Mutated NSCLC

  • Osimertinib receives FDA approval for unresectable Stage III EGFR-mutated NSCLC after chemoradiation, showing a significant increase in progression-free survival.
  • Amivantamab, combined with chemotherapy, gains FDA approval for EGFR exon 19 deletions or exon 21 L858R substitution mutations in NSCLC after EGFR TKI treatment.
  • Clinical trials, including LAURA and MARIPOSA-2, support these approvals, offering new targeted therapy options for patients with advanced NSCLC.

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

NCT04606381Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

NCT05908734Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/18/2023

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

NCT03521154Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/19/2018

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

NCT05488314Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/13/2022

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

NeOnc Technologies Pursues Direct Listing with Intranasal Glioblastoma Therapy

  • NeOnc Technologies is pursuing a direct listing after withdrawing its IPO plans, aiming to fund development of NEO100, an intranasal drug for glioblastoma.
  • NEO100 leverages cranial nerves to bypass the blood-brain barrier, delivering perillyl alcohol (POH) directly to brain tumors, showing promise in early trials.
  • A Phase 1 study demonstrated NEO100's safety and tolerability, with some patients showing extended survival, particularly those with IDH1 mutations.
  • NeOnc's Phase 2a trial is ongoing, focusing on patients with IDH1 mutations, with preliminary data expected in mid-2025, as the company explores novel drug delivery methods.

Durvalumab Combo Shows Sustained PFS Benefit in Advanced Ovarian Cancer

  • Durvalumab plus chemotherapy and bevacizumab, followed by maintenance with olaparib, durvalumab, and bevacizumab, significantly improved progression-free survival (PFS).
  • In patients with BRCA-unmutated, HRD-positive ovarian cancer, median PFS was 45.1 months in the treatment arm versus 23.3 months in the control arm.
  • In the BRCA-unmutated ITT population, median PFS was 25.1 months for the durvalumab combination arm compared to 19.3 months for the control arm.
  • The safety profile of the durvalumab combination was consistent with previous analyses, with manageable adverse events.

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

NCT03737643Active, Not RecruitingPhase 3
AstraZeneca
Posted 1/4/2019

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246Active, Not RecruitingPhase 3
pharmaand GmbH
Posted 5/14/2018

Multidisciplinary Long-Term Care Program Assessed for Pediatric Cancer Survivors

  • A study is underway to evaluate a structured, multidisciplinary long-term care program for pediatric cancer survivors, focusing on improving self-efficacy and overall well-being.
  • The primary outcome measured is self-efficacy, assessed using the General Self-Efficacy Scale adapted for health and healthcare contexts in patients aged 12 and older, and via proxy by parents.
  • Secondary outcomes include satisfaction with healthcare, health-related quality of life (HRQoL), mental health, and transition readiness from pediatric to adult care, utilizing validated questionnaires.
  • The trial involves at least 160 participants from ten pediatric university clinics, aiming to determine the effectiveness of the intervention compared to standard care over a 24-month recruitment period.

rTMS Shows Promise in Improving Functional Outcomes for Multiple Sclerosis Patients

  • A phase II trial is underway to assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with multiple sclerosis (MS).
  • The trial utilizes the Multiple Sclerosis Functional Composite (MSFC) to measure improvements in functional outcomes after rTMS treatment.
  • Patient-reported outcome measures (PROMs) will evaluate the impact of rTMS on anxiety, depression, fatigue, quality of life, and sleep quality.
  • Advanced MRI metrics will be used to assess changes in brain lesions and tissue volume following rTMS intervention.

NEOpredict-Lung Study Shows Promising 2-Year Survival with Nivolumab Plus Relatlimab in NSCLC

  • The NEOpredict-Lung study evaluated the efficacy of nivolumab plus relatlimab in patients with resectable non-small cell lung cancer (NSCLC).
  • Two-year survival data indicates a notable proportion of patients experienced prolonged survival with the combination therapy.
  • The study provides valuable insights into the potential of immunotherapy combinations in improving outcomes for NSCLC patients.
  • Further research is warranted to validate these findings and optimize treatment strategies for this patient population.

FDA Clears Investigational New Drug Application for Adaptin Bio's Glioblastoma Therapy APTN-101

  • The FDA has cleared Adaptin Bio's investigational new drug application for APTN-101, a novel therapy for glioblastoma, a grade 4 malignant glioma.
  • APTN-101 utilizes Adaptin Bio's BRiTE platform to target EGFRvIII, a protein associated with aggressive brain tumors, and enhance T-cell delivery to the brain.
  • A Phase 1 clinical trial will evaluate the safety and efficacy of APTN-101 in patients with glioblastoma, offering a potential new approach to treating this aggressive cancer.
  • Preclinical studies have demonstrated that APTN-101 can cross the blood-brain barrier and effectively eliminate malignant glioma tumors.

Biomarkers Identified to Predict Treatment Response in Psoriatic Arthritis

  • Researchers have identified potential biomarkers, including CXCL10, MMP3, S100A8, ACP5, and CCL2, that may predict treatment response in psoriatic arthritis (PsA).
  • TNF inhibitors (TNFi) reduced serum levels of CXCL10, MMP3, S100A8, ACP5, and CCL2, while Interleukin-17 inhibitors (IL-17i) increased ACP5 and CCL2 in PsA patients.
  • High baseline levels of ACP5 in patients treated with biologics and low baseline levels of MMP3 in untreated patients were predictive of Disease Activity in PSoriatic Arthritis (DAPSA) response.
  • The study highlights the potential use of MMP3, S100A8, ACP5, and CXCL10 as serum biomarkers to predict treatment response in PsA patients.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.