NCT03123783. Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma . 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 . To determine the pharmacokinetics of APX005M.

About this Clinical Trial. 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. About Apexigen. III. About Apexigen. Description This phase I / II trial studies the side effects and best dose of CD40 agonistic monoclonal antibody APX005M when given together with pembrolizumab and to see how well it works in treating patients with stage III-IV melanoma. II. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a .

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. Official Title. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. Recently, for newly diagnosed metastatic pancreatic cancer patients, a result of a phase Ib trial of APX005M and chemotherapy with or without nivolumab reported an ORR of 58% . In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. Apexigen has declared the adult recommended phase 2 dose to be 0.3 mg/kg because no dose limiting toxicities were encountered at that dose and the pharmacodynamic profile was similar to the 1 mg/kg maximally tolerated dose. APX005M is a type of immunotherapy called a monoclonal antibody which may help treat cancer by strengthening the immune system. 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. Apexigen, Inc. Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Head and Neck Neoplasms Melanoma Microsatellite Instability Neoplasms. Phase 1. (Inclusion Criteria) Are you 18 years of age or older? We conducted a multi-center, open label clinical trial to evaluate the combination of APX005M with nivo and standard . Study Type: Interventional 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.

The RP2D for APX005M is 0.3 mg/kg. Ending Trials Early. SAN CARLOS, Calif., April 1, 2019 /PRNewswire/ -- Apexigen, Inc., a clinical-stage biopharmaceutical company, today presented new clinical data on. Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Methods: Pts with untreated mPDAC were rand to 1 of 3 open-label arms: gem/NP . APX005M can trigger activation of B cells, monocytes, and dendritic cells and . In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. 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? 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. . 05/01/2015. 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. Informed Consent.

apx005m is currently in phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation APX005M is evaluated in several trials, one of them in combination with chemotherapy in pancreatic cancer, with encouraging early results (NCT03214250 ) Location . Clinical trial in progress: A phase 1b trial of talimogene laherparepvec (T-VEC) in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation. Pneumonia AND sponsor name. APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort. The goal of Part 2 of this study is to learn if the combination . Indications.

The RP2D for APX005M is 0.3 mg/kg. . This is a brief summary of a clinical trial, a type of therapeutic research study. Description Summary 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. Kenneth Byrd1, Nibedita Chakraborty2, Mehmet Kocak1, Alisa Harber2, Ari Vanderwalde2.

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.

. Patient Safety.

Evaluar la seguridad de APX005M en sujetos con melanoma no resecable o metastsico, no tratados . A point mutation was introduced in the Fc-domain at position 267 from serine to aspartic acid (S267E mutation). For more information on these trials, call AskMDAnderson toll-free at 1-877-632-6789. . APX005M can trigger activation of B cells, monocytes, and dendritic cells and . Country. 2022-04-22. 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 . APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. 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. . About Sotigalimab (APX005M) . The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of .

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. "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. 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. . We are conducting a multi-center, open label Phase Ib/II clinical trial to evaluate the combination of APX005M with nivo in subjects with M or NSCLC. Clinical trial information: NCT02482168. Safety and Tolerability measured by assessing serious adverse events (SAEs)and adverse events (AEs) Time Frame: From study enrollment up to 12 . About Apexigen. A phase III clinical trial enrolling 436 patients affected by unresectable injectable melanoma randomized to receive intralesional T-VEC . The goal of Part 2 of this study is to learn if the combination can help to control . Deciding to Take Part in a Trial. SECONDARY OBJECTIVE: I. APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel. Apexigen, Inc. Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Head and Neck Neoplasms Melanoma Microsatellite Instability Neoplasms.

Ipilimumab is a humanized IgG1 monoclonal antibody directed against CTLA-4.

APX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. This is a multicenter phase I trial of APX005M in patients with recurrent or refractory primary malignant central nervous system tumor, or newly diagnosed diffuse intrinsic pontine glioma.APX005M is a humanized IgG1 mAb that binds to CD40.APX005M binds to both human and cynomolgus monkey CD40 with high affinity, triggering activation of B cells, monocytes, and dendritic cells and stimulating . Findings: Two DLTs, both febrile neutropenia, were observed, occurring in one patient each for cohorts B2 (grade 3) and C1 (grade 4). Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma. [email protected] 28 Argonaut, Suite 150 Aliso Viejo, CA 92656 Phone: (+1) 949-248-RARE (7273) 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 ).

The Nordic Society of Gynaecological Oncology - Clinical Trial Unit is a non-profit organization aiming to improve the practice of prevention, diagnosis and . The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. Recruitment is ongoing, with a target enrollment of approximately 32 subjects across 3 centers in the United States. 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 . To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary . Phase I Study of APX005M in Pediatric CNS Tumors Last Updated: 2022-06-21 Originally Posted: 2017-12-15. Preclinical data suggest that chemotherapy with agonistic CD40 antibodies can be combined with anti-PD-1 to trigger effective T cell immunity. This phase 1 clinical trial is to study APX005M in children with central nervous system tumors. APX005M and the Company's additional preclinical programs were discovered using APXiMABTM .

APX005M is currently in Phase 2 clinical development for the treatment of cancers such as melanoma, non-small cell lung cancer, pancreatic cancer, esophageal and gastroesophageal junction cancers . Full Title Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma (CIRB) Purpose The purpose of this study is to find the highest dose of the investigational immunotherapy drug APX005M that can be given safely in children with brain tumors that .

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 . 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 . I. National Institutes of Health Clinical Center (CC) .

1University of Tennessee Health Science Center, Memphis, TN, USA, Memphis, TN . (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) . Herein, we report results from the follow-on, randomized (rand) ph2 trial evaluating gem/NP nivo APX005M.

APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Secondary objectives include an evaluation of the pharmacokinetic, immune pharmacodynamic and antitumor effects of APX005M. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. 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). Date on which the clinical trial was updated on the clinicaltrials.gov website.

NCT02482168. In contrast, agonism of an IgG2 mAb, such as CP-870,893, is believed to be provided by its unique hinge conformation ( 54, 55 ). In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed.

A randomized phase II .

Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer. In a recently completed clinical trial, APX005M demonstrated robust immune activation and an excellent safety profile. Your Message Will Go To CCTO 650-498-6608

Clinical trials include only patients who choose, or whose parents permit them to take part in the research study. Showing trials for . 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 . 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. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Immunotherapy with APX005M, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. 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 . 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 ]. This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body. Federal Government Programs. Sotigalimab targets CD40, a co-stimulatory receptor that is. 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 . Phase I Study of APX005M in Pediatric CNS Tumors. Indications. APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells. Other agonistic anti-40 agonists, including APX005M, ChiLob 7/4, SEA-CD40, and CDX-1140, did not result in meaningful clinical activity (57-60).