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NCT Number: NCT05098132

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

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.

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Key information

Conditions

Advanced Solid Tumor 1st Line NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Untreated Advanced NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

LTD High Technology Hospital Medcenter, Batumi, Georgia

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About this study

Phase 1: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.

Phase 2: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels 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. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Selected Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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

Treatment and study plan

STK-012

Drug

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

Pembrolizumab KEYTRUDA®

Drug

anti-PD-1 monoclonal antibody

Pemetrexed

Drug

chemotherapy

carboplatin

Drug

chemotherapy

Primary outcomes

  1. Phase 1a: Treatment emergent adverse events (TEAEs)

    Time frame: 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)

    Time frame: 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)

    Time frame: Cycle 1, Days 1 through 21

    Incidence of DLTs in participants with select advanced solid tumors

  4. Phase 1a: Deaths

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From 1st dose of study treatment until death, up to 4 years

    Incidence of death in 1L NSQ NSCLC (PD-L1<1% or STK11m)

Study contacts

Contact information is provided by the study sponsor or research team.

Synthekine STK-012-101 Contact

CONTACT

[email protected]

650-606-6319

Sponsors and collaborators

Lead sponsor

Synthekine

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: SYNERGY-101

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 28, 2021
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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