NCT01514123

Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Completed Phase 1 Last updated 17 September 2020

What this trial tests

Phase 1 trial testing VGX-100 in Neoplasms in 43 participants. Completed in 16 November 2017.

Timeline

29 December 2011

Primary endpoint
7 February 2014

16 November 2017

Quick facts

Lead sponsor	Circadian Technologies Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	29 December 2011
Primary completion	7 February 2014
Estimated completion	16 November 2017
Sites	2 locations across United States

Drugs / interventions tested

• VGX-100 — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Cancer — all drugs for Cancer →

Sponsor

Circadian Technologies Ltd.

Who can join

18 and older, any sex, with Neoplasms or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100 alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100 when administered alone or in combination with bevacizumab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
   Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022
2. Long noncoding RNA BLACAT2 promotes bladder cancer-associated lymphangiogenesis and lymphatic metastasis.
   He W, Zhong G, Jiang N, Wang B, et al · · 2018 · cited 153× · PMID 29355840 · DOI 10.1172/jci96218
3. The Hepatic Lymphatic Vascular System: Structure, Function, Markers, and Lymphangiogenesis.
   Tanaka M, Iwakiri Y. · · 2016 · cited 106× · PMID 28105461 · DOI 10.1016/j.jcmgh.2016.09.002
4. The pre-metastatic niche in lymph nodes: formation and characteristics.
   Gillot L, Baudin L, Rouaud L, Kridelka F, et al · · 2021 · cited 82× · PMID 34241649 · DOI 10.1007/s00018-021-03873-z
5. The lymphatic system and pancreatic cancer.
   Fink DM, Steele MM, Hollingsworth MA. · · 2016 · cited 53× · PMID 26742462 · DOI 10.1016/j.canlet.2015.11.048
6. New Strategies Using Antibody Combinations to Increase Cancer Treatment Effectiveness.
   Corraliza-Gorjón I, Somovilla-Crespo B, Santamaria S, Garcia-Sanz JA, et al · · 2017 · cited 49× · PMID 29312320 · DOI 10.3389/fimmu.2017.01804
7. Two Birds, One Stone: Double Hits on Tumor Growth and Lymphangiogenesis by Targeting Vascular Endothelial Growth Factor Receptor 3.
   Hsu MC, Pan MR, Hung WC. · · 2019 · cited 47× · PMID 30901976 · DOI 10.3390/cells8030270
8. Mechanisms and Clinical Significance of Tumor Lymphatic Invasion.
   Fujimoto N, Dieterich LC. · · 2021 · cited 42× · PMID 34685565 · DOI 10.3390/cells10102585