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New treatment option for Advanced Solid Tumor
Official title Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
ClinicalTrials.gov ID: NCT05098132
What this study is testing
What is STK-012?
STK-012 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Selected
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- Selected
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Santa Monica, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Saint Paul, Minnesota, United States
- Lake Success, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Beverly Hills, California, United States; Fullerton, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.