apx005m clinical trial

In a recently completed clinical trial, APX005M demonstrated robust immune activation and an excellent safety profile. NCT02482168. APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. Abstract. Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System Examples: Cancer AND drug name. To evaluate the safety of CD40 agonistic monoclonal antibody APX005M (APX005M) administered intravenously every 3 weeks to children with central nervous system tumors. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best . This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. APX005M and the Company's additional preclinical programs were discovered using APXiMABTM . Immunotherapy triggers the body's immune system to fight cancer cells. Study Design Go to Resource links provided by the National Library of Medicine APX005M is a monoclonal antibody targeting CD40, a co-stimulatory receptor, and is being evaluated in multiple clinical trials in different types of solid tumours. Clinical trial information: NCT02482168. Clinical trials include only patients who choose, or whose parents permit them to take part in the research study. APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. APX005M is evaluated in several trials, one of them in combination with chemotherapy in pancreatic cancer, with encouraging early results (NCT03214250 ) Location . 05/01/2015. About Apexigen. Eli Lilly and Company "Previously, APX005M has demonstrated safety and activity in a Phase 1 . 4019 Background: Results from a ph1b trial evaluating gem/NP with CD40 agonistic monoclonal antibody APX005M nivo demonstrated promising clinical activity in pts with untreated mPDAC (O'Hara 2021). Primary Objective To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab SECONDARY OBJECTIVE: I. . The RP2D for APX005M is 0.3 mg/kg. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. [email protected] 28 Argonaut, Suite 150 Aliso Viejo, CA 92656 Phone: (+1) 949-248-RARE (7273) II. . APX005M is a humanized IgG1 mAb that binds to CD40. The RP2D for APX005M is 0.3 mg/kg. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. The hypotheses in this study is, that the CD-40 agonist APX005M with or without radiotherapy, and in combination with platinum-doublet chemotherapy, will provide the necessary immune activation and serve as a basis for increased clinical effect of the combination. . National Institutes of Health Clinical Center (CC) . Chemotherapy drugs, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them . Phase I Study of APX005M in Pediatric CNS Tumors. San Carlos, CA, and New Haven, CT - June 14, 2018 - Apexigen, Inc., and Yale Cancer Center today announced a clinical trial collaboration to evaluate Apexigen's APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors. About Sotigalimab (APX005M) Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary . Contacts: Emerging Medicine 855-216-0098 PennCancerTrials@emergingmed.com Publications: Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient's immune system to . ClinicalTrials.gov Identifier: NCT03214250, UPCC 11217 . Phase 1. This is a brief summary of a clinical trial, a type of therapeutic research study. Herein, we report results from the follow-on, randomized (rand) ph2 trial evaluating gem/NP nivo APX005M. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best . One study (clinical trial identifier: NCT03389802) has investigated the potential to overcome resistance to PD-1/PD-L1 blockade immunotherapy by the combination of APX005M with cabiralizumab, an anti-CSF1R antagonist, with and without nivolumab in several solid tumours . A phase III clinical trial enrolling 436 patients affected by unresectable injectable melanoma randomized to receive intralesional T-VEC . Description This pilot phase II trial studies the side effects of CD40 agonistic monoclonal antibody APX005M (APX005M), chemotherapy, and radiation therapy, and to see how well they work when given before surgery in treating patients with esophageal cancer or gastroesophageal cancer that can be removed by surgery. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. Pneumonia AND sponsor name. . Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. In an interim analysis of an ongoing Phase 1b clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumor shrinkage following treatment with APX005M in . Secondary objectives include an evaluation of the pharmacokinetic, immune pharmacodynamic and antitumor effects of APX005M. The purpose of this clinical trial is to evaluate the safety of doxorubicin, olaratumab and APX005M when used together, and to see if this study treatment is effective for patients with Dedifferentiated liposarcoma, Leiomyosarcoma, and Undifferentiated pleomorphic sarcoma Are you Eligible? The names of the study drugs involved in this study are: - Domvanalimab (also known as . Conclusions: APX005M + nivo demonstrated a good safety profile and promising antitumor activity in M subjects with PD while receiving anti-PD-1 therapy and potential activity in NSCLC. . Ending Trials Early. Apexigen, Inc. Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Head and Neck Neoplasms Melanoma Microsatellite Instability Neoplasms. Recruitment is ongoing, with a target enrollment of approximately 32 subjects across 3 centers in the United States. In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. NCT03123783. Insurance Coverage and Clinical Trials. Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. Questions to Ask about Treatment Clinical Trials. We conducted a multi-center, open label clinical trial to evaluate the combination of APX005M with nivo and standard . The study drug APX005M is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial. About Sotigalimab (APX005M) . Preclinical data strongly suggest that combination of a CD40 agonistic antibody with an immune checkpoint inhibitor, such as an anti-PD-1, anti-PD-L1 and/or anti-CTLA4 antibody, will result in synergistic anti-tumor efficacy. APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort. Nivolumab is a humanized IgG4 monoclonal antibody directed against PD-1. Phase 1. A randomized phase II . If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. Deciding to Take Part in a Trial. Indications. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma. APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase 1) followed by a Phase 2 tumor specific portion. Your Message Will Go To CCTO 650-498-6608 1University of Tennessee Health Science Center, Memphis, TN, USA, Memphis, TN . The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. Recruitment is ongoing, with a target enrollment of approximately 32 subjects across 3 centers in the United States. APX005M can trigger activation of B cells, monocytes, and dendritic cells and . This research study involves immunotherapy. APX005M is a humanized IgG1 antibody generated by Apexigen using its APXiMAB technology consisting of a rabbit hybridoma platform and mutational lineage-guided (MLG) humanization method [ 30 - 32 ]. Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from . Date on which the clinical trial was updated on the clinicaltrials.gov website. "We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. Scientific Review. Indications. A point mutation was introduced in the Fc-domain at position 267 from serine to aspartic acid (S267E mutation). Methods: Pts with untreated mPDAC were rand to 1 of 3 open-label arms: gem/NP . Background: Checkpoint inhibitors such as anti-PD-1 are ineffective as single agents for patients (pts) with PDAC. IgG1 Fc domain engineering was employed for APX005M based on the finding in a murine model that the potency of a CD40 agonist can be enhanced by increased binding affinity to FcRIIB ( 52, 53 ). Showing trials for . This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. (n = 12), non-small cell lung cancer (n = 1) and renal cell carcinoma (n = 13), evaluated the safety of the CD40 agonist APX005M (sotigalimab) and CSF1R inhibitor (cabiralizumab) . APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. The trial is a Phase 1, open-label dose-escalation study of APX005M in adults with solid tumors that is intended to establish the maximum tolerated dose, the pharmacokinetic profile and the . Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. Sotigalimab targets CD40, a co-stimulatory receptor that is. Summary This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. To determine the pharmacokinetics of APX005M. Official Title. This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a . Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient's immune system to . About Apexigen. Esophageal Cancer clinical trials at UCSF . APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells. NCT02482168. SAN CARLOS, CA, August 5, 2021 - Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to sotigalimab (APX005M) for the treatment of soft tissue .

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