Clinical Trials - Phase I

Found 19,483 articles

• Vaccinex Completes Enrollment in Phase 1b/2 SIGNAL-AD (Alzheimer’s Disease) Study of Pepinemab

  4/25/2023

  Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that it has completed enrollment goal in the SIGNAL-AD clinical trial for people with mild dementia due to Alzheimer’s Disease (NCT04381468).

• Erasca Announces Publication of Promising Clinical Data Supporting the Therapeutic Potential of Naporafenib in Combination with Trametinib in NRAS-Mutant Melanoma

  4/25/2023

  Erasca, Inc. (Nasdaq: ERAS) today announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label study evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST®) in patients with NRAS-mutant (NRASm) melanoma.

• Stoke Therapeutics Receives Authorization to Initiate a Phase 1/2 Study of STK-002 for Autosomal Dominant Optic Atrophy (ADOA) in the United Kingdom

  4/25/2023

  Stoke Therapeutics, Inc. today announced authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1/2 study (OSPREY) of STK-002 for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder.

• Neurona Therapeutics Presents Updated Data from the NRTX-1001 Cell Therapy Trial in Adults with Drug-resistant Focal Epilepsy at American Academy of Neurology (AAN) 2023 Annual Meeting

  4/24/2023

  Neurona Therapeutics announced the presentation of updated clinical data from its ongoing Phase I/II clinical trial of a single dose of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE).

• IN8bio Presents Positive, New INB-100 Data Showing Long-term Complete Remissions and Elevated Gamma-Delta T Cells in 100% of Evaluable Treated Leukemia Patients at EBMT 2023

  4/24/2023

  IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced new positive data from the Phase 1 investigator-sponsored trial of INB-100 in leukemia patients.

• Successful Results Using Sernova’s Cell Pouch System™ with Evotec’s iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit

  4/24/2023

  Sernova Corp. announced the presentation of preclinical data supporting the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of patients with T1D.

• LIXTE Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced Soft Tissue Sarcoma

  4/24/2023

  LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”) announced that the Spanish Sarcoma Research Group (Grupo Español de Investigación en Sarcomas, or GEIS) completed its first site initiation visit in preparation for the advanced soft tissue sarcoma (ASTS) clinical trial at Fundación Jiménez Díaz University Hospital (Madrid).

• Lexaria Awards CRO Contract for Upcoming U.S. Phase 1b Hypertension Study

  4/24/2023

  Lexaria Bioscience Corp. announces it has awarded the contract for clinical research organization ("CRO") services for its expected upcoming Food and Drug Administration ("FDA")-registered, U.S. Phase 1b Investigational New Drug ("IND") hypertension study HYPER-H23-1 with its patented DehydraTECH-powered cannabidiol ("DehydraTECH-CBD") to California-based InClin, Inc.

• Medigene AG presents final Phase I data of TCR-T cell therapy MDG1011 in patients with high-risk blood cancers

  4/24/2023

  Medigene AG reports final Phase I dose escalation results from first-in-human Study of HLA-A*02:01-restricted PRAME-specific T cell receptor engineered T cell therapy for high-risk myeloid and lymphoid neoplasms.

• Bridge Biotherapeutics Receives FDA Authorization to Proceed with the First-in-Human Study of BBT-207, a 4th generation EGFR TKI

  4/24/2023

  Bridge Biotherapeutics announced that it received notice from the U.S. Food and Drug Administration that it may proceed with the first-in-human study of BBT-207, which has the potential to be a mutant selective and broad-spectrum fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor for the treatment of non-small cell lung cancer.

• Oblato Announces the First Enrollment in a Phase 1 Clinical Trial for an Oral Formulation of OKN-007 in Recurrent High-Grade Glioma Patients in the USA

  4/21/2023

  Oblato, Inc., a subsidiary company of HLB Therapeutics in Korea, has announced the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007.

• Sensei Biotherapeutics Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for SNS-101, a Conditionally Active VISTA-Blocking Antibody

  4/20/2023

  Sensei Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, paving the way for the Company to conduct a Phase 1/2 clinical trial in patients with solid tumors.

• Janux Therapeutics Announces First Patient Dosed with JANX008 in First-in-Human Phase 1 Clinical Trial in Patients with Solid Tumors

  4/20/2023

  Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux) today announced the first patient has been dosed at City of Hope in a Phase 1 clinical trial of JANX008 in subjects with advanced or metastatic solid tumors including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.

• Elucida Oncology Announces Positive Early Phase 1 Safety Data Along with Preclinical Data for the Treatment of Brain Metastases for ELU001, an Anti-Folate Receptor Alpha C’Dot Drug Conjugate

  4/20/2023

  Elucida Oncology, a clinical-stage biotechnology company developing the next frontier in targeted cancer therapy, presented positive initial safety data from Phase 1 dose escalation trial of ELU001 (NCT05001282) in a poster titled “ELU-FRα-1: A Study to Evaluate ELU001, a C’Dot Drug Conjugate, in Patients with Solid Tumors that Overexpress Folate Receptor Alpha (FRα)” (abstract #CT255) at the American Association for Cancer Research (AACR) 2023 Annual Meeting.

• Daré Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%

  4/20/2023

  Daré Bioscience, Inc. (NASDAQ: DARE) and Strategic Science & Technologies, LLC (SST) today announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6% (Sildenafil Cream), a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder (FSAD).

• TriSalus Life Sciences Presents New Data at AACR for SD-101 Delivered by the Proprietary PEDD™ Method in Stage IV Uveal Melanoma Patients With Liver Metastases

  4/20/2023

  TriSalus Life Sciences Presents New Data at AACR for SD-101 Delivered by the Proprietary PEDD ™ Method in Stage IV Uveal Melanoma Patients With Liver Metastases.

• SELLAS Life Sciences Successfully Completes Phase I Trial Dose Escalation of Novel, Highly Selective CDK9 Inhibitor GFH009 in Acute Myeloid Leukemia

  4/20/2023

  SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”) today announced completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia (AML) who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009.

• BioInvent Announces a Fourth Complete Response in Phase 1/2 Trial with BI-1206 in Non-Hodgkin’s Lymphoma

  4/20/2023

  BioInvent International AB announces that a fourth complete response has been observed in the 100 mg dose expansion cohort in the IV arm of the Phase 1/2 trial of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, in combination with rituximab in non-Hodgkin's lymphoma.

• Luxa Biotechnology to Provide Update on Clinical Trial of Retinal Pigmented Epithelium Stem Cell (RPESC) Technology for Treatment of Dry Age-Related Macular Degeneration in Panel Session at ARVO 2023

  4/20/2023

  Luxa Biotechnology today announced the company will provide an update on the progress of a Phase 1/2a clinical trial evaluating transplantation of RPESC-RPE-4W to treat dry age-related macular degeneration (AMD) at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held in New Orleans from April 23– 27, 2023.

• 

  Lilly Seeks First-Line KRAS Treatment with AACR Data Release

  4/19/2023

  Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.