MedPath

Clinical Trial News

DEA Blocks Cannabis Research for Seven Years Despite FDA-Approved Clinical Trials for Huntington's Disease and Multiple Sclerosis

Orphan Drug
  • The DEA has blocked MMJ BioPharma Cultivation from conducting FDA-authorized clinical trials for Huntington's Disease and Multiple Sclerosis for seven years, despite the company's federal compliance and orphan drug designation.
  • Internal DEA quotes reveal systemic incompetence and corruption, with officials admitting ignorance about cannabis regulation while creating bureaucratic barriers that prevent legitimate pharmaceutical research.
  • New DEA Administrator Terrance Cole faces pressure to approve MMJ's Schedule I bulk manufacturing registration after the agency subjected the company to constitutionally defective administrative proceedings.
  • The regulatory obstruction occurs while the DEA promotes unsubstantiated claims comparing cannabis to methamphetamine, highlighting the agency's contradictory approach to cannabis science and public health.

InxMed Reports Breakthrough Results for Ifebemtinib-Garsorasib Combination in KRAS G12C-Mutant Cancers at ASCO 2025

Targeted Therapy
  • InxMed's Phase Ib/II trial data shows ifebemtinib plus garsorasib achieved a median progression-free survival of 22.3 months in first-line NSCLC patients with KRAS G12C mutations.
  • The dual-oral combination demonstrated superior efficacy in colorectal cancer, with objective response rates of 44.4% versus 16.7% for garsorasib monotherapy.
  • The chemotherapy-free regimen showed consistent efficacy regardless of PD-L1 expression status and has prompted initiation of a Phase III pivotal trial.
  • Ifebemtinib has received Breakthrough Therapy Designation from China's NMPA and Fast-Track Designation from the FDA, with regulatory submission planned for 2025.

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

NCT06166836RecruitingPhase 1
InxMed (Shanghai) Co., Ltd.
Posted 10/12/2022

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

NCT05379946Active, Not RecruitingPhase 1
InventisBio Co., Ltd
Posted 10/12/2022

Gut Microbiome Emerges as Key Factor in Cancer Immunotherapy Response and Resistance

  • Research demonstrates that gut microbiota significantly influences cancer treatment outcomes, with disrupted gut bacteria associated with resistance to immunotherapies and chemotherapy.
  • Clinical trials show promising results for microbiome-targeted interventions, including fecal microbiota transplantation achieving 66.7% progression-free survival in renal cell carcinoma patients and 80% overall response rate in lung cancer.
  • Multiple biotechnology companies are developing novel treatments that leverage gut bacteria, including Enterome's OncoMimics peptides and MaaT Pharma's microbiome ecosystem therapy, both advancing through Phase 2 and 3 trials.
  • Antibiotic use poses significant risks to cancer patients by reducing microbiome diversity and impairing immune responses, with studies showing increased death risk and reduced immunotherapy effectiveness.

Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma

NCT04951583Active, Not RecruitingPhase 2
Centre hospitalier de l'Université de Montréal (CHUM)
Posted 11/16/2021

Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Renal Cell Carcinoma

NCT04758507CompletedPhase 1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Posted 2/18/2021

LBL-024 Bispecific Antibody Shows 75% Response Rate in Advanced Neuroendocrine Carcinoma Trial

  • Leads Biolabs' LBL-024, a first-in-class PD-L1/4-1BB bispecific antibody, achieved a 75% overall response rate in 52 patients with advanced extrapulmonary neuroendocrine carcinoma when combined with chemotherapy.
  • The optimal 15 mg/kg dose demonstrated an 83.3% response rate and 100% disease control rate, significantly outperforming historical chemotherapy-alone data of 30-55%.
  • LBL-024 has received breakthrough therapy designation in China and orphan drug designation from the FDA, positioning it as a potential first approved treatment specifically for EP-NEC.
  • The drug showed manageable safety profile with no dose-limiting toxicities observed during phase Ib dose escalation, with most adverse events being Grade 1-2.

A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

NCT06157827RecruitingPhase 1
Nanjing Leads Biolabs Co.,Ltd
Posted 12/8/2023

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma

NCT07099430RecruitingNot Applicable
Nanjing Leads Biolabs Co.,Ltd
Posted 9/5/2025

NeoCOAST-2 Trial Shows Promise for Novel Pre-Surgical Combinations in Resectable NSCLC

  • The Phase II NeoCOAST-2 trial evaluated three novel pre-surgical treatment combinations for resectable non-small cell lung cancer, with the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) arm achieving the highest pathological complete response rate at 35.2%.
  • All three treatment arms demonstrated promising pathological response rates while maintaining manageable safety profiles and surgical feasibility, with over 93% of patients successfully undergoing surgery.
  • The study represents the first global Phase II trial to report clinical data on an antibody-drug conjugate in the neoadjuvant setting for resectable NSCLC patients.

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

NCT02998528CompletedPhase 3
Bristol-Myers Squibb
Posted 3/4/2017

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

NCT03425643Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/24/2018

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

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

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

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

NCT03800134Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/6/2018

Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

NCT04379739Active, Not RecruitingPhase 2
Shanghai Pulmonary Hospital, Shanghai, China
Posted 7/26/2020

Avistone's Dual-Target Therapy Shows 50% Response Rate in EGFR-Resistant Lung Cancer at ASCO 2025

  • Avistone's combination therapy Vebreltinib plus Andamertinib achieved a 50% overall response rate in 56 patients with EGFR-mutated NSCLC who developed resistance through MET amplification or overexpression.
  • The Phase Ib/II KYLIN-1 study demonstrated a median progression-free survival of 9.9 months with manageable safety, as only 19.6% of patients experienced grade 3 or higher treatment-related adverse events.
  • A Phase III KYLIN-3 study is currently ongoing to compare the combination therapy against platinum-based chemotherapy in this challenging patient population.
  • The therapy showed promising activity in brain metastases, with a 42.1% response rate and 9.5 months median progression-free survival in 19 patients with central nervous system involvement.

Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

NCT06343064RecruitingPhase 1
Avistone Biotechnology Co., Ltd.
Posted 6/13/2023

Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure

NCT06970782Not Yet RecruitingPhase 3
Avistone Biotechnology Co., Ltd.
Posted 5/15/2025

AstraZeneca Advances Two Phase III Trials Testing Baxdrostat Combination Therapy for Cardiovascular and Kidney Disease

  • AstraZeneca is conducting two Phase III clinical trials evaluating baxdrostat in combination with dapagliflozin for patients with cardiovascular disease and chronic kidney disease.
  • The first study targets patients aged 40 and older with type 2 diabetes, established cardiovascular disease, and hypertension, focusing on heart failure and cardiovascular outcomes.
  • The second trial investigates baxdrostat/dapagliflozin efficacy in patients 18 years and older with chronic kidney disease and hypertension over a 24-month treatment period.
  • Both studies include run-in periods with dapagliflozin monotherapy and feature comprehensive follow-up protocols with visits extending up to 34 weeks in the cardiovascular trial.

AstraZeneca Advances AZD0022, Novel Oral KRASG12D Inhibitor, in First-in-Human Phase I/IIa Trial

Monoclonal AntibodyTargeted TherapyOncology
  • AstraZeneca is developing AZD0022, a potent oral KRASG12D-selective inhibitor that demonstrates robust pathway inhibition and anti-tumor activity in preclinical models.
  • The drug is currently being investigated in the ALAFOSS-01 study, a first-in-human Phase I/IIa trial for patients with KRASG12D-mutated solid tumors.
  • Preclinical data shows enhanced therapeutic responses when AZD0022 is combined with cetuximab, with sustained tumor regressions observed in colorectal and pancreatic cancer models.
  • The clinical trial includes both monotherapy and combination therapy modules, targeting multiple cancer types including colorectal, lung, and pancreatic cancers.

A trial to learn how safe AZD0022 is, how well it works, and how it moves throughout the body over time in adults with tumors that have a KRAS-G12D mutation, when given alone and with other cancer drugs

2024-516699-14-00RecruitingPhase 1/2
AstraZeneca AB
Posted 10/18/2024

AstraZeneca Initiates Phase II Trial of AZD7798 for Crohn's Disease Mucosal Repair

  • AstraZeneca has launched the CALLISTO Phase II clinical trial to evaluate AZD7798, an experimental treatment targeting mucosal repair in patients with active ileal Crohn's disease and ileostomy.
  • The randomized, placebo-controlled study will enroll approximately 30 participants globally for a 12-week induction period followed by a 40-week open-label maintenance phase.
  • The trial began recruitment on December 11, 2024, with primary completion expected after the initial 12-week induction phase.
  • This study represents AstraZeneca's commitment to developing innovative gastrointestinal treatments and could position the company favorably in the competitive Crohn's disease therapeutic market.

China Approves First Domestically Developed 9-Valent HPV Vaccine, Becomes Second Country with Independent High-Valency HPV Production

Drug Approval
  • China has approved its first domestically developed nine-valent HPV vaccine, Cecolin 9, making it only the second country after the United States with independent high-valency HPV vaccine production capability.
  • Clinical trials involving over 11,000 participants demonstrated over 98% protection against persistent HPV infections and 100% protection against cervical infections for the targeted viral strains.
  • The vaccine offers a two-dose regimen for girls aged 9-17, providing immune responses comparable to three-dose schedules in older populations, with efficacy lasting at least 30 months.
  • This achievement builds on China's previous success with its domestically produced two-valent HPV vaccine, which received WHO prequalification in 2021 and has entered 21 international markets.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.