GIM-531 / Georgiamune - LARVOL DELTA

GIM531-CT01: Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=117 | Recruiting | Sponsor: Georgiamune Inc | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

First-in-human • IO biomarker • Trial completion date • Trial primary completion date • Breast Cancer • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • BRAF

GIM531-CT01: Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=117 | Recruiting | Sponsor: Georgiamune Inc | N=84 ➔ 117

Enrollment change • Melanoma • Oncology • Solid Tumor

Georgiamune Announces First Patient Dosed in A First-In-Class Phase 1 Cancer Treatment Trial of GIM-531 (GlobeNewswire) - "Today, Georgiamune...announced that the first patient has been dosed with GIM-531 in a first-in-human, phase 1 clinical trial for the treatment of advanced cancer patients....The phase 1 trial will evaluate the safety profile, pharmacokinetics, and pharmacodynamic effects; as well as inform the dose, schedule and early anti-tumor activity of GIM-531 for patients with advanced solid tumors that have progressed on or have been intolerant of available therapies. Following the completion of the dose escalation, two additional study cohorts will be initiated for GIM-531, a single agent to be explored in a solid tumor where T-regulatory cells play an important role in the failure of the immune system to fight cancer and a combination with anti-PD-1 in anti-PD-1 failure advanced melanoma."

Trial status • Melanoma

Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Georgiamune Inc | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Melanoma • Oncology • Solid Tumor

Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Georgiamune Inc

New P1/2 trial • Melanoma • Oncology • Solid Tumor