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Clinical Trial News

Ifinatamab Deruxtecan Shows Promise in Extensive-Stage Small Cell Lung Cancer

  • Interim analysis of the IDeate-Lung01 phase II trial reveals that ifinatamab deruxtecan (I-DXd) demonstrates promising activity in pretreated patients with extensive-stage small cell lung cancer (SCLC).
  • Patients treated with I-DXd 12 mg/kg showed a confirmed objective response rate (ORR) of 54.8%, more than double the 26.1% ORR in the 8 mg/kg cohort.
  • The disease control rate was also higher in the 12-mg/kg group, at 90.5% versus 80.4% in the 8-mg/kg group, showcasing the potential of I-DXd in managing this aggressive cancer.
  • I-DXd at 12 mg/kg is currently being evaluated in the ongoing phase III IDeate-Lung02 trial, building on the encouraging phase II results.

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

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

NCT05338970Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 7/8/2022

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

2023-509628-16-00RecruitingPhase 3
Daiichi Sankyo Inc.
Posted 5/21/2024

CBD Shows Promise in Extending Lifespan and Alleviating Symptoms of Leigh Syndrome in Preclinical Models

  • A new study reveals that cannabidiol (CBD) significantly extends lifespan and alleviates symptoms in animal models of Leigh syndrome, a severe mitochondrial disease.
  • Researchers found that CBD activates PPARγ, a protein that regulates genes involved in mitochondrial function, immune responses, and oxidative stress, improving cellular function.
  • CBD treatment in animal models led to improvements in brain function, motor skills, and neurological health, suggesting its potential to extend life expectancy in Leigh syndrome.
  • The EMA has granted CBD orphan drug designation for Leigh syndrome, potentially accelerating clinical trials, especially with existing FDA approval for other pediatric diseases.

Recent Advances in Oncology: FDA Approvals, Promising Therapies, and Evolving Treatment Strategies

• The FDA approved inavolisib plus palbociclib/fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- advanced breast cancer, significantly improving progression-free survival. • Zolbetuximab combined with chemotherapy received FDA approval for first-line treatment of CLDN18.2+ gastric or GEJ adenocarcinoma, based on positive results from SPOTLIGHT and GLOW trials. • Neoadjuvant pembrolizumab followed by adjuvant pembrolizumab demonstrated a significant improvement in event-free survival in resected stage III/IVA head and neck squamous cell carcinoma.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

NCT03653507Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 11/28/2018

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

NXC-201 (formerly HBI0101) Multiple Myeloma

NCT04720313Active, Not RecruitingPhase 1
Hadassah Medical Organization
Posted 1/1/2021

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

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

NCT02784171CompletedPhase 2
Canadian Cancer Trials Group
Posted 11/11/2016

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

NCT02972840Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 4/5/2017

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT06128044TerminatedPhase 1
Caribou Biosciences, Inc.
Posted 2/8/2024

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

NCT03675737CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/8/2018

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedNot Applicable
BeiGene
Posted 12/11/2018

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

NCT03765918Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/17/2018

Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

NCT04527991CompletedPhase 3
Gilead Sciences
Posted 1/13/2021

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

NCT05091567Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/18/2021

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197Active, Not RecruitingPhase 3
Pfizer
Posted 12/18/2017

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)

NCT02973789CompletedPhase 3
NovoCure GmbH
Posted 12/1/2016

A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation

NCT04625270Active, Not RecruitingPhase 2
Verastem, Inc.
Posted 12/21/2020

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

NCT03143153CompletedPhase 3
Bristol-Myers Squibb
Posted 6/29/2017

A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

NCT05094336RecruitingPhase 1
Amgen
Posted 2/1/2022

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

NCT04211337Active, Not RecruitingPhase 3
Loxo Oncology, Inc.
Posted 2/11/2020

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

NCT03189719CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 7/25/2017

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

NCT02872116CompletedPhase 3
Bristol-Myers Squibb
Posted 10/12/2016

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

NCT03504397Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 6/21/2018

Duchenne Muscular Dystrophy: Balancing Gene Therapy's Promise with Evolving Treatment Landscape

  • The FDA's approval of Elevidys has expanded the treatment landscape for Duchenne muscular dystrophy (DMD), offering new hope but also complicating treatment decisions.
  • Real-world experience with Elevidys highlights the need for long-term data, especially in older patients, to fully understand its benefits and risks.
  • Research is ongoing to address challenges associated with DMD gene therapy, including immune responses and the need for more potent delivery vehicles.
  • Experts emphasize the importance of educating clinicians and families about the benefits and risks of Elevidys and other DMD treatments.

Bicara Therapeutics and Zenas BioPharma Aim for $200 Million IPOs

• Bicara Therapeutics plans a $200 million IPO to advance ficerafusp alfa, a bifunctional antibody targeting EGFR and TGF-β for solid tumors. • Zenas BioPharma also seeks $200 million through an IPO to support obexelimab, a CD19 and FcγRIIb targeting antibody in Phase 3 for IgG4-RD. • Both companies anticipate using the IPO proceeds to fund clinical trials and further develop their respective pipelines of novel therapeutics. • The IPOs reflect continued investor interest in innovative biotech companies developing targeted therapies for cancer and autoimmune diseases.

ERS Congress 2024 Addresses Critical Ethical Challenges of AI in Clinical Decision-Making

  • The European Respiratory Society Congress 2024 highlighted key ethical principles for AI integration in healthcare, including patient autonomy, beneficence, and the need for explainable AI systems.
  • Studies revealed significant accuracy concerns in AI healthcare applications, with one system missing 67% of sepsis cases and showing bias in diagnosing conditions across different demographic groups.
  • AI's environmental impact raises sustainability concerns, with healthcare AI technologies projected to consume as much power as Japan by 2026, prompting discussions on balancing innovation with ecological responsibility.

Pembrolizumab Shows Promise in Bowel Cancer Trial, Eradicating Disease in All Patients

  • A clinical trial using pembrolizumab showed a 100% disease-free rate in bowel cancer patients with a specific genetic profile.
  • 59% of patients treated with pembrolizumab had no signs of cancer after treatment, while the remaining 41% had cancer removed via surgery.
  • The trial suggests pembrolizumab is a safe and effective treatment, potentially improving outcomes for high-risk bowel cancer patients.
  • Further research is needed to confirm these early results and assess the long-term efficacy of pembrolizumab in bowel cancer treatment.

FDA Grants Breakthrough Therapy Designation to Sanbexin for Acute Ischemic Stroke

  • The FDA has granted Breakthrough Therapy Designation to Simcere Pharmaceuticals' Sanbexin (edaravone and dexborneol sublingual tablets) for acute ischemic stroke (AIS).
  • The designation is based on Phase 3 TASTE-SL study data showing improved functional outcomes in AIS patients treated within 48 hours of stroke onset.
  • Sanbexin is a brain cytoprotective agent with synergistic anti-oxidant and anti-inflammatory effects, designed for rapid sublingual absorption.
  • Clinical trials demonstrated a comparable safety profile to placebo, with similar rates of adverse events between the Sanbexin and placebo groups.

Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke

NCT04950920CompletedPhase 3
Peking University Third Hospital
Posted 6/28/2021

MRD Testing Evolution and Clinical Applications in Lymphoma Explored at SOHO 2024

  • Next-generation sequencing and ctDNA assays have significantly advanced minimal residual disease (MRD) testing, enhancing sensitivity across lymphoma subtypes.
  • Clinical trials are increasingly utilizing MRD status to guide lymphoma therapy, influencing treatment escalation, de-escalation, consolidation, and therapy initiation/cessation.
  • Research is paving the way for personalized lymphoma treatments using ctDNA assays, which offer insights into tumor biology and may transform clinical decision-making.

Ocuphire Pharma Initiates Phase 3 Trial of Phentolamine Ophthalmic Solution for Presbyopia

  • Ocuphire Pharma has dosed the first patient in its Phase 3 VEGA-3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia.
  • Phentolamine ophthalmic solution 0.75% is under development as a non-invasive alternative to traditional presbyopia treatments.
  • The VEGA-3 trial (NCT06542497) aims to assess the efficacy and safety of this novel ophthalmic solution.

Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

NCT06542497Active, Not RecruitingPhase 3
Ocuphire Pharma, Inc.
Posted 8/15/2024

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