> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-stk-012-alone-and-with-other-treatments-in-patients-74f1c502-c539-4991-b304-12ad967527b4 > Record changed: 2026-10-13 # Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers NCT05098132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Participants 364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Lead sponsor Synthekine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Start date 2022-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) Number of sites 47 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Title and summary **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 or STK11 mutated, non-squamous, non-small cell lung cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Acronym** SYNERGY-101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Short title** Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Official title** 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](https://clinicaltrials.gov/study/NCT05098132) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Dates **Completion date** 2029-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **First posted** 2021-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Registry last updated** 2026-07-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Primary completion date** 2029-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Start date** 2022-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Size and sites **Participants** 364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Planned participants** 364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Number of sites** 47 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Lead sponsor** Synthekine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Identifiers **Registry ID** NCT05098132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **ClinicalTrials.gov ID** NCT05098132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Outcomes ### Primary outcomes 1. Phase 1a: Treatment emergent adverse events (TEAEs) Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of TEAEs in participants with select advanced solid tumors 2. Phase 1a: Serious adverse events (SAEs) Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of SAEs in participants with select advanced solid tumors 3. Phase 1a: Dose limiting toxicities (DLTs) Timeframe: Cycle 1, Days 1 through 21 Incidence of DLTs in participants with select advanced solid tumors 4. Phase 1a: Deaths Timeframe: From 1st dose of study treatment until death, up to 4 years Incidence of death in participants with select advanced solid tumors 5. Phase 1b: TEAEs at the RP2D Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors 6. Phase 1b: SAEs at the RP2D Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of SAEs at the RP2D in participants with select advanced solid tumors 7. Phase 1b: Deaths at the RP2D Timeframe: From 1st dose of study treatment until death, up to 4 years Incidence of death at the RP2D in participants with select advanced solid tumors 8. Phase 2: Overall response rate (ORR) in Arm A versus Arm C Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years To compare the ORR in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR. ### Secondary outcomes 1. Phase 1: ORR Timeframe: From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years Assessment of preliminary efficacy, specifically ORR, in select advanced solid tumors. ORR is the proportion of subjects with confirmed CR or confirmed PR per investigator assessment. 2. Phase 1: Progression free survival (PFS) Timeframe: From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors. 3. Phase 1: Overall survival (OS) Timeframe: From enrollment until death due to any cause, up to 4 years Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors. 4. Phase 1/2: STK-012 ADAs Timeframe: From screening through 30 days after last dose of STK-012 Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors. 5. Phase 1/2: AUC of STK-012 Timeframe: From screening through 30 days after last dose of STK-012 Area under the curve (AUC) to assess pharmacokinetic (PK) characterization of STK-012 in advanced NSCLC and other select solid tumors. 6. Phase 1/2: Cmax of STK-012 Timeframe: From screening through 30 days after last dose of STK-012 Maximum concentration (Cmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors. 7. Phase 1/2: Tmax of STK-012 Timeframe: From screening through 30 days after last dose of STK-012 Time of maximum concentration (Tmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors. 8. Phase 1/2: Half life of STK-012 Timeframe: From screening through 30 days after last dose of STK-012 Half life (t1/2) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors. 9. Phase 2: PFS in Arm A versus Arm C Timeframe: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years To compare the PFS in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first. 10. Phase 2: ORR in Arm B versus Arm C Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years To compare the ORR in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR. 11. Phase 2: PFS in Arm B versus Arm C Timeframe: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years To compare the PFS in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first. 12. Phase 2: OS in Arm A versus C Timeframe: From randomization until death due to any cause, up to 4 years To compare the OS in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). OS is the time from randomization until death due to any cause. 13. Phase 2: OS in Arm B versus C Timeframe: From randomization until death due to any cause, up to 4 years To compare the OS in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) subjects treated with STK-012 1.5 mg + SoC vs. SoC (Arms B vs. C). OS is the time from randomization until death due to any cause. 14. Phase 2: TEAEs Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of TEAEs in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) 15. Phase 2: SAEs Timeframe: From 1st dose of study treatment through 90 days after last dose Incidence of SAEs in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) 16. Phase 2: Deaths Timeframe: From 1st dose of study treatment until death, up to 4 years Incidence of death in 1L NSQ NSCLC (PD-L1\\<1% or STK11m) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 meningitis Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Sites - University of Arizona Cancer CenterTucson, United StatesRecruiting - Beverly Hills Cancer CenterBeverly Hills, United StatesRecruiting - Providence Medical FoundationFullerton, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesActive, not recruiting - Cedars SinaiLos Angeles, United StatesRecruiting - Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting - UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesRecruiting - Yale New Haven Hospital, Yale Cancer CenterNew Haven, United StatesRecruiting - Georgetown UniversityWashington D.C., United StatesRecruiting - Winship Cancer Institute, Emory UniversityAtlanta, United StatesRecruiting - University of ChicagoChicago, United StatesRecruiting - University of MarylandBaltimore, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - HealthPartners Cancer Center at Regions HospitalSaint Paul, United StatesRecruiting - Northwell HealthLake Success, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Columbia University Irving Medical CenterNew York, United StatesActive, not recruiting - Memorial Sloan-Kettering Cancer CenterNew York, United StatesRecruiting - Duke Cancer CenterDurham, United StatesActive, not recruiting - University Hospitals ClevelandCleveland, United StatesRecruiting - The James Cancer Hospital and Solove Research InstituteColumbus, United StatesRecruiting - Providence Cancer InstitutePortland, United StatesRecruiting - Fox Chase Cancer CenterPhiladelphia, United StatesRecruiting And 22 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## References ### Other registry identifiers (3) - 2025 - 2025-522632-14-00 - KEYNOTE-G63 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05098132) ## Related records ### Drugs (3) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Synthekine](https://trialight.com/data/company/synthekine-9c9a740a-5195-41b4-9459-117fcb0db0ff.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (4) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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