R-5780 / Rise Therap - LARVOL DELTA

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Rise Therapeutics LLC | Trial completion date: Dec 2027 ➔ Sep 2029 | Trial primary completion date: Apr 2027 ➔ Mar 2029

Checkpoint inhibition • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • BRAF

R-5780, a SagA-engineered Lactococcus lactis, is a safe oral synthetic-biology microbial therapy that potentiates PD-1 blockade. (PubMed, Cancer Immunol Immunother) - "In murine toxicology studies, R-5780 was well tolerated, with no adverse events or systemic inflammation observed following oral administration. Together, these results identify R-5780 as a safe and potent NOD2 activator that synergizes with PD-1 blockade to enhance antitumor immunity and support its advancement toward clinical evaluation."

IO biomarker • Journal • Colorectal Cancer • Oncology • Oral Cancer • Solid Tumor • CD8 • HAVCR2 • IL1B • LAG3 • NLRC5

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Rise Therapeutics LLC | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Rise Therapeutics LLC | Trial completion date: Sep 2026 ➔ Dec 2027 | Trial primary completion date: Mar 2026 ➔ Apr 2027

Checkpoint inhibition • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Rise Therapeutics Receives FDA IND Clearance to Initiate Clinical Testing of R-5780 in Cancer (PRNewswire) - "Rise Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780. This is Rise Therapeutics' fourth clinical program to enter patient clinical testing....The Phase I clinical trial (NCT06398418) will be a multi-dose clinical trial assessing the safety, drug exposure, and clinical activity of R-5780 in patients with cancer. The study will enroll up to 33 participants."

IND • Solid Tumor

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Rise Therapeutics LLC | Initiation date: Sep 2024 ➔ Mar 2025

Trial initiation date • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Rise Therapeutics LLC | Initiation date: Jun 2024 ➔ Sep 2024

Checkpoint inhibition • Combination therapy • Immune cell • Trial initiation date • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Rise Therapeutics LLC

Checkpoint inhibition • Combination therapy • Immune cell • New P1 trial • Basal Cell Carcinoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma