P1, N=36, Recruiting, Impact Biotech Ltd | Suspended --> Recruiting

This multicenter phase 1 study sought to determine the MTD of oral Lisavanbulin in combination with standard RT (60 Gy/30 fractions) but without temozolomide in patients with newly diagnosed MGMT promoter unmethylated GBM (uGBM). Avanbulin exposures increased in a relatively dose-proportional manner with increasing oral dose of Lisavanbulin from 4 to 15 mg. Lisavanbulin in combination with RT was considered safe up to the highest predefined oral dose level of 15 mg daily.

P1, N=36, Suspended, Impact Biotech Ltd | Trial completion date: Dec 2027 --> Dec 2028 | Not yet recruiting --> Suspended | Trial primary completion date: May 2026 --> May 2027

AI-powered spatial analysis suggests that combination therapy with Pexa-vec and cemiplimab enhances the immune response, evidenced by increased TIL densities in the tumor microenvironment.

P1, N=30, Recruiting, Impact Biotech Ltd | Active, not recruiting --> Recruiting

P2, N=15, Terminated, Dana-Farber Cancer Institute | Active, not recruiting --> Terminated; Trial stopped at request of VBL Therapeutics, as they are no longer pursuing their VB-111 development program.

Notably, treatment with a combination of CA4P, iRGD, and polymersomes loaded with a novel anthracycline Utorubicin (UTO-PS) resulted in a significant decrease in the overall tumor burden in PC-bearing mice, while avoiding overt toxicities. Our results indicate that VDA-treated tumors can be targeted therapeutically using iRGD-potentiated nanotherapy and warrant further studies on the sequential targeting of VDA-induced molecular signatures.

P4, N=43, Terminated, Boston Scientific Corporation | N=100 --> 43 | Trial completion date: Jun 2027 --> Apr 2024 | Active, not recruiting --> Terminated; Enrollment challenges and a difficult insurance coverage landscape

P4, N=10, Terminated, University of Edinburgh | N=120 --> 10 | Unknown status --> Terminated

P1, N=30, Active, not recruiting, Impact Biotech Ltd | Not yet recruiting --> Active, not recruiting

P4, N=100, Active, not recruiting, Boston Scientific Corporation | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> Apr 2024

Our study has originally uncovered a novel cross-species pathway underlying the antitumor vascular disruption of DMXAA extends beyond STING activation. This finding deepens our understanding of the multifaceted actions of flavonoid VDAs in animal models and in clinical settings, and may provide insights for the precise therapy of DMXAA based on the biomarker CapG protein.

P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Mar 2024 --> Aug 2024

P=N/A, N=2000, Not yet recruiting, Universitaire Ziekenhuizen KU Leuven

P3, N=100, Recruiting, Steba Biotech S.A. | Trial primary completion date: Feb 2024 --> Dec 2024

P1, N=10, Not yet recruiting, Massachusetts General Hospital

P1, N=36, Not yet recruiting, Impact Biotech Ltd | Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2026

P1, N=30, Not yet recruiting, Impact Biotech Ltd | Trial completion date: Oct 2025 --> Oct 2026 | Initiation date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2025

Analysis of sequential tissue biopsies and plasma samples revealed an increase in CD8 density and upregulation of immune-related protein biomarkers, including CXCL10.Intra-tumoral administration of JX-594 in combination with cyclophosphamide and avelumab is safe and capable of modulating the TME in cold STS. However, the limited efficacy observed warrants further research to define the therapeutic potential of oncolytic viruses, particularly in relation to specific histological subtypes of STS.

P4, N=100, Recruiting, Boston Scientific Corporation | Trial completion date: Nov 2026 --> Jun 2027 | Trial primary completion date: Feb 2024 --> Sep 2024

P1, N=30, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting

In patients with MSS CLM, VB-111 and nivolumab did not improve overall response rate or survival but were tolerated with minimal toxicities. While challenging to distinguish between antiviral or antitumor, correlative studies demonstrated an immune response with activation and proliferation of CD8 T cells systemically that was poorly sustained.

VEGF/rGel-PCI describes a novel concept for ICI enhancement which induces a rapid CD8+ dependent tumor eradication in both CT26 and MC38 tumors. The concept is based on the combination of intracellular ROS generation and vascular targeting using a plant derived toxin and will be developed towards clinical utilization.

P1, N=30, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Completed --> Active, not recruiting | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024

CYT997 is a potentially efficacious and non-toxic drug candidate for HCC therapy. Its ability to down-regulate GPC3, β-catenin, and c-Myc highlights a novel mechanism of action.

P1, N=30, Not yet recruiting, Massachusetts General Hospital

P1, N=20, Recruiting, Massachusetts General Hospital

P1, N=40, Recruiting, Columbia University | Trial primary completion date: Sep 2023 --> Sep 2024

P1/2, N=34, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed

P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Oct 2023 --> Mar 2024

Percutaneous sclerotherapy with polidocanol appears to be a safe alternative for treatment of aneurysmal bone cysts. In our series of both primary and recurrent cysts, it showed the ability to achieve healing or stable disease in 22 of 23 cases (96%). Further studies are needed to decide if this provides a long-lasting effect.

A drug delivery system was developed, consisting of gemcitabine (GEM) and thermo-sensitive hydrogel (PLGA-PEG-PLGA, PPP)...The therapeutic effects of GEM/PPP hydrogel on xenograft mice were compared with those of GEM, ethanol and polidocanol using the precisely targeted EUS-FNI technology...The combination of GEM/PPP hydrogel and EUS-FNI technology provides an optimal approach of precise chemotherapy for pancreatic cancer, builds a bridge for clinical translation of basic research, and brings great hope for innovation of minimally invasive treatment modalities. The first-hand EUS image data obtained in this study also serves as a crucial reference for future clinical trials.

The most common treatment-related adverse event was pyrexia, with a Grade ≥ 3 of 13.3% in Arm A, 0% in Arm B,0% in Arm C, and 3.6% in Arm D. No Grade 5 events occurred in any of the study arms. Table: 1885P Summary of efficacy results Conclusions The combination immunotherapy of IV PV and cemiplimab demonstrated an acceptable safety profile and encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment.

P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Jun 2023 --> Oct 2023

P1, N=30, Not yet recruiting, Steba Biotech S.A.

P1, N=36, Not yet recruiting, Steba Biotech S.A.

Clone EPR24075-418 showed the best result in assessing the expression of FGFR2: the correlation with FISH results in reaction 3+ was 100%. Due to the high heterogeneity of FGFR2 expression, it is recommended to either examine the material of the primary tumor and metastasis, or evaluate a large volume of the primary tumor.

Due to its unique binding to the colchicine site of tubulin, differently from other MTAs, avanbulin has previously shown activity in solid tumor cell lines. Half of the cell lines tested showed an induction of apoptosis already in the first 24 h of treatment, the other half in the first 48 h. EB1 showed expression in DLBCL clinical specimens, opening the possibility for a cohort of patients that could potentially benefit from treatment with lisavanbulin. These data show the basis for further preclinical and clinical evaluation of lisavanbulin in the lymphoma field.

P2, N=10, Terminated, SynCore Biotechnology Co., Ltd. | N=37 --> 10

P2, N=37, Terminated, SynCore Biotechnology Co., Ltd. | N=10 --> 37

P1, N=12, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025