Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

Allowed: BRAF v600e

Must have received: any prior therapy

Disease progression confirmed by imaging or other objective evidence after having received standard treatment or patients with refractory solid tumors. Patients must have progressed or are intolerant of at least one line of prior therapy.

Must have received: taxane — advanced, metastatic or [neo]adjuvant

Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a taxane and/or anthracycline-based therapy and, where appropriate, an approved checkpoint inhibitor.

Must have received: anthracycline — advanced, metastatic or [neo]adjuvant

Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a taxane and/or anthracycline-based therapy and, where appropriate, an approved checkpoint inhibitor.

Must have received: checkpoint inhibitor — where appropriate

Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a taxane and/or anthracycline-based therapy and, where appropriate, an approved checkpoint inhibitor.

Must have received: anti-PD-1 therapy

Received an anti-programmed death-1 (PD-1) / programmed death ligand-1 (PD-L1) inhibitor as monotherapy or in combination with anti-cytotoxic lymphocyte associated protein 4 (CTLA-4) inhibitor and have either primary or secondary checkpoint inhibitor resistance as per Society for Immunotherapy of Cancer (SITC) consensus definition, unless deemed intolerable by the investigator.

Must have received: anti-PD-L1 therapy

Received an anti-programmed death-1 (PD-1) / programmed death ligand-1 (PD-L1) inhibitor as monotherapy or in combination with anti-cytotoxic lymphocyte associated protein 4 (CTLA-4) inhibitor and have either primary or secondary checkpoint inhibitor resistance as per Society for Immunotherapy of Cancer (SITC) consensus definition, unless deemed intolerable by the investigator.

Must have received: anti-CTLA-4 therapy

Received an anti-programmed death-1 (PD-1) / programmed death ligand-1 (PD-L1) inhibitor as monotherapy or in combination with anti-cytotoxic lymphocyte associated protein 4 (CTLA-4) inhibitor and have either primary or secondary checkpoint inhibitor resistance as per Society for Immunotherapy of Cancer (SITC) consensus definition, unless deemed intolerable by the investigator.

Must have received: BRAF inhibitor

Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (mitogen-activated protein kinase [MAPK] kinase [MEK] inhibitors), unless deemed intolerable by the investigator.

Must have received: MEK inhibitor

Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (mitogen-activated protein kinase [MAPK] kinase [MEK] inhibitors), unless deemed intolerable by the investigator.

Cannot have received: IL-12 therapy

Prior IL-12 therapy.

Cannot have received: direct radiation therapy to the tumor lesion to be injected

Prior direct radiation therapy to the tumor lesion to be injected.