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

NCT05098132 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2026-03-18

No results posted yet for this study

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, non-squamous, non-small cell lung cancer.

Conditions

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

Interventions

DRUG

STK-012

Engineered Interleukin-2 (IL-2) selective for antigen activated T cells

DRUG

pembrolizumab

anti-PD-1 monoclonal antibody

DRUG

pemetrexed

chemotherapy

DRUG

carboplatin

chemotherapy

Sponsors & Collaborators

  • Synthekine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098132 on ClinicalTrials.gov