Brief Title: STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: 1 cycle (21 days)

Primary Outcome 2 - Measure: Adverse events

Primary Outcome 2 - Timeframe: From 1st dose of STK-012 through 90 days after last dose of STK-012

CONDITION

• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma
• Malignant Melanoma
• Renal Cell Carcinoma
• Cervical Cancer
• Microsatellite Instability High
• Gastric Cancer
• GastroEsophageal Cancer
• Urothelial Carcinoma
• Mismatch Repair Deficiency

ELIGIBILITY

Selected Inclusion Criteria
In dose-escalation (Phase 1a), patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment

- Available archived tumor tissue sample. In the setting where archival material is unavailable or unsuitable for use, the patient must consent and undergo fresh tumor biopsy. In some patients, a new pre-treatment and on-treatment tumor biopsy may be required.

- Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
Selected Exclusion Criteria:
Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.

- Received definitive radiotherapy within 2 weeks of the first dose of study treatment; or palliative radiotherapy (defined as < 2 weeks of radiotherapy to non-central nervous system [CNS] disease) within 1 week of the first dose of study treatment. - Received prior IL-2-based or IL-15-based cytokine therapy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 650-271-9888

Email: clinicaltrialinfo@synthekine.com

LOCATION