Patients

First-in-class transformational medicines for cancer patients

We believe that cancer patients seeking clinical trials deserve experimental treatments that have transformational potential, not just incremental improvements over existing therapies. Our overarching goal is to leverage cutting-edge discoveries in how the immune system interacts with cancer cells into new medicines that act in fundamentally different ways than any other drug that has been made before.

Patients

We are proud to have advanced ST-067, an innovative experimental cancer therapy to patients in a Phase 1/2 study in the US. ST-067 is also under study in two investigator-initiated studies in hematological indications. We are also planning additional clinical studies with ST-067 and developing new therapeutic candidates.

Phase 1a and Phase 2 Study for PK, PD, Safety and Preliminary Efficacy of ST 067 (NCT04787042)

Intervention:

Biological: ST-067 – an engineered variant of human interleukin-18.

Trial Status:

Recruiting

Trial Information:

This Phase 1a open-label, dose escalation study of ST-067 given with or without obinunuzumab pretreatment and in combination with pembrolizumab focused on enrolling patients with solid tumors.

If you are a healthcare professional interested in learning more about Simcha’s current studies, please contact: info@simchatherapeutics.com

DR-18 for the Treatment of Relapsed or Persistent Acute Myeloid Leukemia or Myelodysplastic Syndrome After Hematopoietic Cell Transplantation, the DR. DREAM Trial (NCT06492707 ST-067)

Intervention:

ST-067 monotherapy

Trial Status:

Recruiting

Trial Information:

This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT).

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma (NCT0658860)

Intervention:

ST-067 in combination with teclistamab

Trial Status:

Recruiting

Trial Information:

This study, sponsored by the University of Washington, will test ST-067 in combination with teclistamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory).