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Clinical Trial News

I-Mab's Uliledlimab Plus Toripalimab Shows Promise in NSCLC Combination Therapy

  • I-Mab reported encouraging Phase Ib/II trial data for uliledlimab combined with toripalimab in treatment-naïve advanced non-small cell lung cancer (NSCLC).
  • The combination therapy demonstrated a 31.3% objective response rate (ORR) in the efficacy evaluable population, regardless of PD-L1 and CD73 expression.
  • Patients with high CD73 expression (CD73High) showed a higher ORR (53%) compared to those with low CD73 expression (CD73Low, 18%).
  • I-Mab plans to initiate a biomarker-guided pivotal trial to further evaluate the combination and its potential impact on NSCLC patient outcomes.

Ribociclib Shows Promise in Broad Early Breast Cancer Population

  • Ribociclib, a CDK4/6 inhibitor, has demonstrated a statistically significant overall survival benefit in advanced breast cancer, prompting investigation into its efficacy in early breast cancer (EBC).
  • The NATALEE trial is evaluating ribociclib plus endocrine therapy (ET) compared to ET alone in a wide range of patients with HR+/HER2- EBC, addressing an unmet need for those with stage II and III disease.
  • NATALEE includes a broader patient population than previous trials, such as monarchE, including node-negative patients and those with stage II and III disease, reflecting real-world clinical scenarios.
  • The trial uses a 400-mg starting dose of ribociclib, aiming to improve tolerability and adherence while maintaining efficacy, potentially minimizing dose-dependent toxicities.

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

NCT02684032CompletedPhase 1
Celcuity Inc
Posted 6/14/2016

A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

NCT03966898Unknown StatusPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 7/19/2019

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

NCT05296746RecruitingPhase 2
SOLTI Breast Cancer Research Group
Posted 5/3/2022

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

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

NCT05501886RecruitingPhase 3
Celcuity Inc
Posted 12/8/2022

Update on the Efficacy of Venetoclax for Chronic Lymphocytic Leukemia

Recent clinical trials have highlighted the efficacy of Venetoclax, both as a monotherapy and in combination with other treatments, for chronic lymphocytic leukemia (CLL). Studies show significant improvements in progression-free survival (PFS) and overall survival (OS) rates, especially in high-risk patient populations. The combination of Venetoclax with anti-CD20 monoclonal antibodies and Bruton’s tyrosine kinase inhibitors has shown promising results, offering deep and durable remissions. Additionally, measurable residual disease (MRD) assessments are becoming crucial in guiding treatment duration and cessation, with evidence supporting the re-initiation of Venetoclax therapy in relapsed patients.

Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

NCT04608318Active, Not RecruitingPhase 3
German CLL Study Group
Posted 3/1/2021

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT04169737RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 7/29/2020

A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT05057494Active, Not RecruitingPhase 3
AstraZeneca
Posted 9/12/2022

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

NCT04895436RecruitingPhase 2
AbbVie
Posted 3/28/2022

USDA Approves First Therapeutic Treatment for Canine Parvovirus Using Monoclonal Antibody Technology

Monoclonal AntibodyDrug Approval
  • The USDA has granted conditional license for Elanco's Canine Parvovirus Monoclonal Antibody, marking the first approved therapeutic solution to treat canine parvovirus.
  • In efficacy studies, all 28 treated puppies survived with significantly faster recovery times for vomiting, inappetence, and lethargy compared to traditional supportive care.
  • The single intravenous dose treatment could reduce hospitalization costs and make parvovirus treatment more accessible to pet owners who previously couldn't afford intensive care.
  • This breakthrough represents the first monoclonal antibody treatment for Elanco and addresses a critical unmet need in veterinary medicine for a disease with over 90% fatality rate if untreated.

FDA Approves First Gene Therapy, Vijuvek, for Rare Skin Disease Epidermolysis Bullosa

  • The FDA has approved Vijuvek, a topical gene therapy developed by Krystal Biotech, as the first treatment of its kind for epidermolysis bullosa (EB).
  • Clinical trials demonstrated Vijuvek's effectiveness in healing wounds and preventing new blisters in patients with EB, offering a significant improvement in their quality of life.
  • The therapy, while promising, comes with a high annual cost of up to $500,000, raising concerns about accessibility and affordability for patients.
  • Vijuvek offers hope for increased mobility and independence for individuals with EB, potentially transforming the lives of those affected by this debilitating condition.

Neuralink and Paradromics Advance Brain-Computer Interface Technology with FDA

• Neuralink received FDA approval to launch its first-in-human clinical study, marking a significant step for its brain implant technology. • Paradromics secured Breakthrough Device designation from the FDA for its Connexus Direct Data Interface, aimed at aiding communication for paralyzed patients. • Both companies are part of the burgeoning brain-computer interface (BCI) industry, which seeks to treat neurological conditions and restore motor function. • Neuralink's technology aims to enable control of electronic devices via brain signals, while Paradromics focuses on translating neural signals into text or speech.

Tvardi Therapeutics to Present Phase 1 Trial Data of STAT3 Inhibitor TTI-101 at ASCO 2023

Tvardi Therapeutics, Inc. is set to present clinical results from the Phase 1 study of TTI-101, a STAT3 inhibitor, at the ASCO 2023 annual meeting. The study focuses on the safety, tolerability, and clinical activity of TTI-101 monotherapy in patients with advanced solid tumors.

A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

NCT05440708RecruitingPhase 1
Tvardi Therapeutics, Incorporated
Posted 3/23/2023

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

NCT05384119TerminatedPhase 1
Tvardi Therapeutics, Incorporated
Posted 1/9/2023

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

NCT05671835Active, Not RecruitingPhase 2
Tvardi Therapeutics, Incorporated
Posted 5/15/2023

BIAL R&D Doses First Patient in Phase 2 Trial of BIA 28-6156 for Parkinson's Disease with GBA1 Mutation

  • BIAL R&D has dosed the first patient in its Phase 2 ACTIVATE study, evaluating BIA 28-6156 for Parkinson's disease patients with a GBA1 gene mutation.
  • The ACTIVATE study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the efficacy, safety, and tolerability of BIA 28-6156 at two fixed dose levels.
  • BIA 28-6156 is a novel allosteric activator of beta-glucocerebrosidase (GCase), designed to enhance enzyme activity and potentially delay motor progression in GBA-PD patients.
  • The trial will enroll approximately 237 genetically confirmed GBA-PD subjects across sites in North America and Europe, with results expected to inform future treatment strategies.

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

NCT05819359Active, Not RecruitingPhase 2
Bial R&D Investments, S.A.
Posted 3/31/2023

Vega Therapeutics' VGA039 Receives FDA Orphan Drug Designation for Von Willebrand Disease

  • Vega Therapeutics' VGA039, a first-in-class antibody, has been granted Orphan Drug Designation by the FDA for treating von Willebrand disease (VWD).
  • VGA039 modulates Protein S to enhance thrombin generation, addressing a core mechanism of clot formation in VWD.
  • A Phase 1 clinical study (NCT05776069) is underway in the EU and US to assess VGA039's safety, tolerability, and pharmacokinetics in healthy volunteers and VWD patients.
  • VGA039, designed for subcutaneous self-administration, aims to reduce the treatment burden associated with current VWD therapies.

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

NCT05776069RecruitingPhase 1
Vega Therapeutics, Inc
Posted 3/16/2023

Valbiotis Announces Success of REVERSE-IT Clinical Study on TOTUM-63

Valbiotis SA has reported significant success in the REVERSE-IT Phase II/III clinical study on TOTUM-63, showing its efficacy in reducing fasting blood glucose in prediabetic and untreated type 2 diabetic patients. This achievement has triggered a CHF 4 million payment from Nestlé Health Science as part of their global strategic partnership.

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