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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1a: Treatment emergent adverse events (TEAEs)

Primary Outcome 1 - Timeframe: From 1st dose of study treatment through 90 days after last dose

Primary Outcome 2 - Measure: Phase 1a: Serious adverse events (SAEs)

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

Primary Outcome 3 - Measure: Phase 1a: Dose limiting toxicities (DLTs)

Primary Outcome 3 - Timeframe: Cycle 1

Primary Outcome 4 - Measure: Phase 1a: Deaths

Primary Outcome 4 - Timeframe: Days 1 through 21

Primary Outcome 5 - Measure: Phase 1b: TEAEs at the RP2D

Primary Outcome 5 - Timeframe: From 1st dose of study treatment until death

Primary Outcome 6 - Measure: Phase 1b: SAEs at the RP2D

Primary Outcome 6 - Timeframe: up to 4 years

Primary Outcome 7 - Measure: Phase 1b: Deaths at the RP2D

Primary Outcome 7 - Timeframe: From 1st dose of study treatment through 90 days after last dose

Primary Outcome 8 - Measure: Phase 2: Overall response rate (ORR) in Arm A versus Arm C

Primary Outcome 8 - Timeframe: From 1st dose of study treatment through 90 days after last dose

CONDITION

• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Untreated Advanced NSCLC
• 1st Line NSCLC

ELIGIBILITY

Selected Inclusion Criteria:
1. Phase 1: Selected advanced solid tumors

- 2. Phase 2:
* Diagnosis of non-small cell lung cancer (NSCLC).

- * Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.

- * Non-squamous (NSQ) cell histology.

- * No prior systemic therapy for advanced/metastatic NSQ NSCLC.

- * Must have a tumor that meets at least one of the following criteria on local testing:
* PD-L1 negative (TPS <1%), OR; - * STK11 mutated on tumor tissue or ctDNA - * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.
Selected Exclusion Criteria:
2. Phase 2:
* Prior immune checkpoint inhibitor (anti-PD[L]1 and/or anti-CTLA-4) treatment

- * Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).

- * Received radiotherapy ≤ 7 days of the first dose of study treatment.

- * Known active central nervous system metastases

- * Any history of carcinomatous meningitis

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: Synthekine STK-012-101 Contact

Phone: 650-606-6319

Email: [email protected]

LOCATION