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:
1. Participants enrolled to STK-012 monotherapy dose escalation and expansion and STK-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.

- 2. Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease.

- 3. Participants enrolled to STK-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have NSCLC and may not have received treatment for metastatic disease.

- 4. Participants enrolled to STK-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have PD-L1 negative NSCLC and may not have received treatment for metastatic disease.
Selected Exclusion Criteria:
1. 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.

- 2. Received radiotherapy within 2 weeks of the first dose of study treatment.

- 3. Received prior IL-2-based or IL-15-based cytokine therapy.

- 4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

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: Clinical Operations

Phone: 650-271-9888

Email: [email protected]

LOCATION