Clinical trial · Interventional
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 1st Line NSCLC | — | UNRESOLVED | — |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Untreated Advanced NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pembrolizumab KEYTRUDA® | Drug | Pembrolizumab | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| STK-012 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Phase 1a: STK-012 monotherapy dose escalation
- description
- STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
- interventionNames
- Drug: STK-012
- type
- EXPERIMENTAL
- label
- Phase 1a: STK-012 + pembrolizumab dose escalation
- description
- STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
- interventionNames
- Drug: STK-012
- Drug: pembrolizumab KEYTRUDA®
- type
- EXPERIMENTAL
- label
- Phase 1a: STK-012 + standard of care (SoC) dose escalation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Selected Inclusion Criteria:
1. Phase 1: Selected advanced solid tumors
2. 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 meningitisReferences
Publications (0)
Data not yet available