Synthekine, Inc., STK-012-10, Ph1/2, randomized, NSCLC & select indications,STK-012 +/- combo chemo

Purpose of Study

What is the Purpose of this Study?

Primary Objective: Phase 2 To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25mg + PCT vs. PCT (Arms A vs. C) Secondary Objectives: To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C) To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C) To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To assess the safety of STK-012 therapy in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT vs. PCT To assess the immunogenicity of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT To assess the PK of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT


Study Eligibility

Eligibility


  • 1. Phase 1 \[closed to enrollment\]
  • 2. Phase 2 \[open to enrollment\]:
  • * Diagnosis of non-small cell lung cancer (NSCLC).
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Study Sites

Where can I participate?



  • CS Cancer at Beverly Hills : Brian Minton
  • CS Cancer at Cedars-Sinai Medical Center : Brian Minton


More about this Clinical Trial

What is the full name of this clinical trial?

STK-012-101: A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

Study Details
Disease Type/Condition

Cervix, Lung, Melanoma, Other Urinary, Stomach, Unknown Sites

Principal Investigator
1

Reckamp, Karen

Co-Investigators

Amin Mirhadi, David Hoffman, Jeremy Lorber, Kamya Sankar, Kevin Scher

Age Group

Adult

Phase

I/II

IRB Number

STUDY00004639

ClinicalTrials.gov ID

NCT05098132

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Name

Brian Minton

Email

[email protected]
Study Detail
Disease Type/Condition

Cervix, Lung, Melanoma, Other Urinary, Stomach, Unknown Sites

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

I/II

IRB Number

STK-012-101

ClinicalTrials.gov ID

NCT05098132

Key Eligibility
ClinicalTrials.gov

Contact
Name

Brian Minton

Email
[email protected]