dalnicastobart (LVGN7409)
/ Lyvgen
- LARVOL DELTA
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September 13, 2025
CD40 Agonist and PD-1 Inhibitor in HNSCC
(clinicaltrials.gov)
- P1 | N=27 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting | N=20 ➔ 27
Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
November 04, 2024
Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
(clinicaltrials.gov)
- P1 | N=352 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting
Combination therapy • Enrollment closed • Metastases • Esophageal Cancer • Eye Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40
October 31, 2024
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
(clinicaltrials.gov)
- P1 | N=126 | Active, not recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Recruiting ➔ Active, not recruiting | Phase classification: P1a/1b ➔ P1 | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025
Combination therapy • Enrollment closed • Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology
July 19, 2024
CD40 Agonist and PD-1 Inhibitor in HNSCC
(clinicaltrials.gov)
- P1 | N=20 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting
Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
April 19, 2024
Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy
(clinicaltrials.gov)
- P1 | N=33 | Completed | Sponsor: Lyvgen Biopharma Holdings Limited | Terminated ➔ Completed
IO biomarker • Metastases • Trial completion • Tumor mutational burden • Oncology • CD4 • CD40 • IFNG • IL12A • IL6 • PD-L1 • TMB • TNFA
December 29, 2023
Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy
(clinicaltrials.gov)
- P1 | N=33 | Terminated | Sponsor: Lyvgen Biopharma Holdings Limited | N=93 ➔ 33 | Trial completion date: Apr 2024 ➔ Dec 2023 | Recruiting ➔ Terminated; The study was terminated due to product development strategy adjustment,there were no safety concerns
Enrollment change • IO biomarker • Metastases • Trial completion date • Trial termination • Tumor mutational burden • Oncology • CD4 • CD40 • IFNG • IL12A • IL6 • PD-L1 • TMB • TNFA
December 16, 2023
Harnessing the potential of CD40 agonism in cancer therapy.
(PubMed, Cytokine Growth Factor Rev)
- "In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them."
IO biomarker • Journal • Review • Oncology • CD40 • CD40LG • CD8 • TNFA
December 07, 2023
CD40 Agonist and PD-1 Inhibitor in HNSCC
(clinicaltrials.gov)
- P1 | N=20 | Not yet recruiting | Sponsor: University of Pennsylvania
New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
September 15, 2023
Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
(clinicaltrials.gov)
- P1 | N=352 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2023 ➔ Feb 2027 | Trial primary completion date: Jul 2023 ➔ Feb 2027
Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40
June 23, 2023
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
(clinicaltrials.gov)
- P1a/1b | N=126 | Recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024
Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology
April 28, 2022
Early safety and efficacy from a phase I open-label clinical study of LVGN7409 (CD40 agonist antibody) in patients with advanced or metastatic malignancies.
(ASCO 2022)
- P1a/1b | "An open-label, first in human phase 1 study of LVGN7409 as a single agent, combined with LVGN3616 (anti-PD-1 antibody), and combined with LVGN3616 and LVGN6051 (CD137 agonist antibody) is ongoing. Preliminary evidence showed LVGN7409 monotherapy was well tolerated up to 2mg/kg. Approximately 44% of stable diseases were observed in these heavily treated patients. The favorable safety profile and preliminary antitumor activity warrant further evaluation of LVGN7409 as a single agent and in combination with other cancer therapeutics in patients with advanced malignancies."
Clinical • IO biomarker • P1 data • Immune Modulation • Inflammation • Oncology • CD40
March 08, 2023
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
(clinicaltrials.gov)
- P1a/1b | N=126 | Recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Trial completion date: Apr 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023
Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology
November 27, 2022
Lyvgen Announces Phase 2 Clinical Collaboration with Bristol Myers Squibb to Evaluate LVGN7409 in Combination with Nivolumab in Non-Small Cell Lung Cancer Patients
(PRNewswire)
- "Lyvgen Biopharma...announced today an open label, phase 2, multicenter, randomized trial of LVGN7409 plus docetaxel or, in collaboration with Bristol Myers Squibb, nivolumab in patients with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)....LVGN7409, a recombinant monoclonal antibody that targets CD40 for activation optimally in tumor microenvironment, which is a member of the tumor necrosis factor (TNF) receptor family (TNFRSF5)....Under the terms of the Agreement, Lyvgen will sponsor the study and Bristol Myers Squibb will provide nivolumab for the combination trial....Combination study to begin in 1st half 2023."
Licensing / partnership • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer
December 09, 2021
Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy
(clinicaltrials.gov)
- P1; N=93; Recruiting; Sponsor: Lyvgen Biopharma Holdings Limited
Clinical • New P1 trial • Oncology • Solid Tumor • CD4
November 26, 2021
Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
(clinicaltrials.gov)
- P1; N=352; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2022 ➔ Nov 2021
Combination therapy • Enrollment open • Trial initiation date • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40
October 13, 2021
Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
(clinicaltrials.gov)
- P1; N=352; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center
Combination therapy • New P1 trial • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40
January 15, 2021
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
(clinicaltrials.gov)
- P1a/1b; N=126; Recruiting; Sponsor: Lyvgen Biopharma Holdings Limited; Not yet recruiting ➔ Recruiting
Clinical • Combination therapy • Enrollment open • Oncology
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