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Amivantamab Plus Chemotherapy Shows Promise in Metastatic Colorectal Cancer

  • RYBREVANT® (amivantamab) combined with chemotherapy demonstrated a 49% overall response rate in patients with RAS/BRAF wild-type metastatic colorectal cancer.
  • The median duration of response was 7.4 months, and the median progression-free survival was 7.5 months in the study population.
  • Notably, 21% of patients were able to undergo curative-intent surgery due to the treatment's strong antitumor activity.
  • The safety profile of the combination was manageable, with no new safety signals observed beyond those of the individual components.

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

NCT04606381RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

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 Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer

NCT06385080RecruitingPhase 1
Janssen Research & Development, LLC
Posted 4/22/2024

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

NCT05908734RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/18/2023

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

NCT05379595RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/29/2022

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 Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

NCT06532032Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/23/2024

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

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 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

Silk-Derived Protein Shows Promise in Treating Severe Dry Eye Disease

  • A novel silk-derived protein, SDP-4, has demonstrated safety and efficacy in alleviating symptoms of severe dry eye disease (DED).
  • The protein mimics those found on the ocular surface and aims to restore the protective tear film.
  • The study, published in the American Journal of Ophthalmology, suggests SDP-4 as a multi-modal treatment option for DED.

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

NCT04719832CompletedPhase 3
GlaxoSmithKline
Posted 3/17/2021

A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

NCT04718103CompletedPhase 3
GlaxoSmithKline
Posted 2/4/2021

Perioperative Nivolumab and Neoadjuvant Immunotherapy Show Promise in Resectable NSCLC

  • Perioperative nivolumab significantly extends event-free survival (EFS) in resectable NSCLC, with a median EFS increase from 17.0 to 40.1 months.
  • Neoadjuvant nivolumab, alone or with ipilimumab, demonstrates durable long-term survival benefits, particularly in patients achieving major pathological response (MPR) or pathological complete response (PCR).
  • Circulating tumor DNA (ctDNA) clearance during neoadjuvant therapy is a potential biomarker, with higher clearance rates observed in the nivolumab group and correlation with PCR achievement.
  • Biomarker analysis suggests PD-L1 positivity may predict better EFS with nivolumab monotherapy, while KRAS co-mutations may benefit more from nivolumab plus ipilimumab.

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

NCT02259621Active, Not RecruitingPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 9/1/2014

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

NCT03158129CompletedPhase 2
M.D. Anderson Cancer Center
Posted 6/16/2017

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

NCT04025879Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 11/5/2019

Mirvetuximab Soravtansine Shows Promise in Platinum-Sensitive Ovarian Cancer

  • Mirvetuximab soravtansine demonstrates a 51.9% overall response rate in heavily pretreated, FRα-positive, platinum-sensitive ovarian cancer patients.
  • The PICCOLO trial highlights the drug's efficacy even in patients previously treated with PARP inhibitors, with a 45.8% response rate.
  • The treatment shows a manageable safety profile, with mostly mild side effects, offering a potential alternative to traditional doublet therapies.
  • The findings suggest mirvetuximab soravtansine could address unmet needs in patients ineligible for repeat platinum therapy due to toxicity.

Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)

NCT05041257CompletedPhase 2
AbbVie
Posted 8/31/2021

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

NCT04209855CompletedPhase 3
AbbVie
Posted 12/31/2019

Replimune's RP1 Shows Durable Responses in Anti-PD1 Failed Melanoma

  • Replimune presented positive primary analysis data from the IGNYTE trial of RP1 combined with nivolumab in patients with melanoma who failed anti-PD1 therapy.
  • The study showed an overall response rate of 33.6% and a complete response rate of 15% by mRECIST criteria, with a median duration of response of 27.6 months.
  • One-, two-, and three-year survival rates were 75.3%, 63.3%, and 54.8%, respectively, and the combination therapy was well-tolerated with mostly Grade 1-2 adverse events.
  • Replimune plans to submit a Biologics License Application (BLA) for RP1 in anti-PD1 failed melanoma in the second half of 2024.

High-Dose Vitamin D3 Fails to Improve Outcomes in Metastatic Colorectal Cancer

  • A phase 3 clinical trial (SOLARIS) found that high-dose vitamin D3, when added to standard chemotherapy plus bevacizumab, did not improve progression-free survival in patients with metastatic colorectal cancer.
  • The study, involving over 450 patients, showed no significant difference in cancer progression between those receiving high-dose versus standard-dose vitamin D3 after a median follow-up of 20 months.
  • While high-dose vitamin D3 did not demonstrate overall benefit, a potential benefit was observed in patients with left-sided primary tumors, warranting further investigation.
  • The findings suggest that high-dose vitamin D3 is not recommended as a treatment for patients with untreated metastatic colon cancer, despite prior research suggesting a link between vitamin D levels and survival.

AMBASSADOR Trial: Pembrolizumab Shows Sustained DFS Benefit in High-Risk Bladder Cancer

  • Extended follow-up from the AMBASSADOR trial demonstrates that adjuvant pembrolizumab significantly improves disease-free survival (DFS) in high-risk muscle-invasive urothelial carcinoma.
  • At 45 months, pembrolizumab nearly doubled median DFS compared to observation (29.6 vs. 14.2 months), showing a sustained clinical benefit in this setting.
  • The DFS benefit with pembrolizumab was observed regardless of PD-L1 status or lymph node involvement, suggesting broad applicability in the studied population.
  • The study highlights the potential for future perioperative strategies and combination therapies, emphasizing the need for biomarkers to refine patient selection and treatment approaches.

Scorpion Therapeutics' STX-478 Shows Promise in Phase 1/2 Trial for Advanced Solid Tumors

  • STX-478, an oral PI3Kα inhibitor, demonstrated anti-tumor activity in a Phase 1/2 trial, with an overall response rate of 23% in breast cancer patients.
  • The trial included patients with HR+/HER2- breast cancer, gynecological tumors, and head and neck squamous cell cancer, showing efficacy across multiple cancer types.
  • STX-478 exhibited a favorable safety profile, with most adverse events being mild to moderate and no discontinuations due to treatment-related adverse events.
  • The pharmacokinetic profile of STX-478 supports once-daily dosing, with exposures exceeding those needed for in vivo efficacy and target coverage.

First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

NCT05768139RecruitingPhase 1
Scorpion Therapeutics, Inc.
Posted 4/17/2023

DAV132 Adsorbent Does Not Interfere with Plasma Concentrations of Key Antibiotics

  • A randomized, controlled study (CL-006) found that DAV132, a colon-targeted adsorbent, did not significantly alter plasma concentrations of ceftriaxone, piperacillin, tazobactam, ceftazidime, and avibactam.
  • The study involved 148 healthy volunteers who received DAV132 at two different doses (7.5g or 12g) in combination with antibiotics or without antibiotics over 7 days.
  • Exploratory analyses suggest DAV132 may protect the intestinal microbiome diversity during antibiotic treatment, warranting further investigation into its potential role in mitigating antibiotic-associated dysbiosis.
  • Research in mice suggests DAV132 may enhance the efficacy of anti-PD-1 immunotherapy by modulating the gut microbiota and immune response, offering a potential strategy to overcome resistance.

WHO Prequalifies MVA-BN Mpox Vaccine, Boosting Global Access

  • The World Health Organization (WHO) has prequalified the MVA-BN vaccine, marking it as the first mpox vaccine to receive this designation, ensuring faster access.
  • This prequalification is based on data from Bavarian Nordic and a review by the European Medicines Agency, the regulatory agency of record for the vaccine.
  • The MVA-BN vaccine, administered in two doses four weeks apart for adults, can be stored at 2–8°C for up to eight weeks after prior cold storage.
  • WHO urges increased procurement, donations, and rollout of the vaccine to ensure equitable access alongside other public health measures to combat mpox.

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