Round Lake Beach, Illinois

Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non-Hodgkin’s Lymphoma

This is a multi-center Phase 1/2 open label trial of G100 in patients with low grade NHL. G100 is composed of glucopyranosyl lipid A in a stable emulsion (GLA-SE) and is a potent TLR4 (toll-like receptor-4 agonist. In this study, G100 will be administered by direct injection (intratumorally) into tumors of low-grade NHL patients following standard low dose radiation therapy. Preclinical models and clinical studies in other cancers such as Merkel cell carcinoma have demonstrated that G100 administered in this manner can alter the tumor microenvironment, activate dendritic cells, T cells and other immune cells and induce systemic anti-tumor immune responses. In this trial, the safety, immunogenicity, and clinical efficacy of G100 will be examined alone or with pembrolizumab. This study will have two phases. In Part 1, Dose Escalation, two sequentially enrolled cohorts of patients will be treated at one of 2 dose levels of G100 using a standard escalation design. This study will have two phases. In Part 1, Dose Escalation, two sequentially enrolled cohorts of patients will be treated at one of 2 dose levels of G100 using a standard escalation design. In this portion of the study, both follicular and marginal zone NHL will eligible. In Part 2, 2 groups of patients with follicular NHL may be examined. One group will be randomly assigned to receive either single agent G100 intratumorally at the maximum safe dose determined in Part 1 following local radiation or will receive the same treatment regimen sequentially administered with pembrolizumab. A second treatment group may be explored if the safety profile in Part 1 is acceptable. In this optional group, patients with injectable tumors of 4 cm or greater would be enrolled and treated with a higher dose of G100. The primary goal of this study is to determine the safety and tolerability of different doses of G100 when administered by intratumoral injection. The development of anti-tumor immune responses and preliminary evidence of clinical responses in local and distal tumor sites will also be examined. Study Contact Information: Debi Kadoun Phone: 253-428-8752 Email: [dkadoun@nwmsonline.com](mailto:dkadoun@nwmsonline.com) Linda Dhaene Phone: 253-428-8753 Email: [ldhaene@nwmsonlin.com](mailto:ldhaene@nwmsonlin.com)