Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

About

Brief Summary

This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Selected Inclusion Criteria:

Phase 1: Selected advanced solid tumors
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

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