CBL0137 IA / Incuron, Statera BioPharma - LARVOL DELTA

A phase 1 study of intra-arterial CBL0137 in extremity melanomas and sarcomas. (PubMed, Surg Oncol) - "The historic restrictions of standard regional therapies may be overcome with IA CBL0137, and this treatment is potentially applicable to a wide range of cancers beyond the extremities."

Journal • P1 data • Melanoma • Oncology • Sarcoma • Solid Tumor

NCI-2018-01928: CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Roswell Park Cancer Institute | N=36 ➔ 7 | Trial completion date: Aug 2024 ➔ Jan 2024 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2024 ➔ Jan 2024; low accrual

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Early Observations from Clinical Trial of Intra-arterial Curaxin CBL0137 (SSO 2022) - P1 | "Preclinical murine isolated limb studies of CBL0137 showed superior efficacy to melphalan with reduced toxicity and serve as the basis for an on-going clinical trial of intra-arterial (IA) administration in locally advanced extremity melanoma and sarcoma patients. The first 3 patients treated in the rapid dose escalation phase demonstrate the safety of the drug at early doses. Unappreciated at the time the trial was written, patients with lymphedema, venous obstruction, disease too proximal for tourniquet, and active lifestyles showed no evidence of “functional” toxicity that can be associated with ILI or ILP. Potential responses were noted at doses expected to be below presumed therapeutic threshold."

Clinical • Gastric Cancer • Inflammation • Melanoma • Oncology • Sarcoma • Solid Tumor • Venous Thromboembolism

CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial completion date: Aug 2022 ➔ Aug 2024; Trial primary completion date: Aug 2021 ➔ Aug 2024

Clinical • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor