NCT05098132 Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
| NCT ID | NCT05098132 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Synthekine |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 364 participants |
| Start Date | 2022-01-25 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 364 participants in total. It began in 2022-01-25 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, non-squamous, non-small cell lung cancer.
Eligibility Criteria
Selected Inclusion Criteria: 1. Phase 1 \[closed to enrollment\] 2. Phase 2 \[open to enrollment\]: * 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. * Tumor is PD-L1 negative (TPS \<1%) by local testing. * 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: 1. Phase 1 \[closed to enrollment\] 2. Phase 2 \[open to enrollment\]: * Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment * Tumor with small cell, neuroendocrine, or sarcomatoid components. * Received radiotherapy ≤ 7 days of the first dose of study treatment. * Known untreated central nervous system metastases * Any history of carcinomatous meningitis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05098132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05098132 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05098132 currently recruiting?
Yes, NCT05098132 is actively recruiting participants. Contact the research team at STK-012-101.contact@synthekine.com for enrollment information.
Where is the NCT05098132 trial being conducted?
This trial is being conducted at Tucson, United States, Beverly Hills, United States, Fullerton, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT05098132 clinical trial?
NCT05098132 is sponsored by Synthekine. The trial plans to enroll 364 participants.