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Advanced Solid TumorPhase 1/2SYNERGY-101NCT05098132

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

A Phase 1/2 study testing STK-012, pembrolizumab KEYTRUDA® and pemetrexed in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Synthekine at 60 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
STK-012, pembrolizumab KEYTRUDA® and pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
60 sitesin 6 countries
Study dates
25 Jan 2022to Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:

  1. 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

Trial locations and contacts

60 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Synthekine STK-012-101 Contact contact

650-606-6319

STK-012-101.contact@synthekine.com

60 sites in 6 countries

United States35 sites, 26 recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106

    Recruiting

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Renovatio Clinical

    El Paso, Texas, 79915

    Withdrawn

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

  • Oncology Consultants

    Houston, Texas, 77303

    Recruiting

  • Mayo Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

    Active, not recruiting

  • Northwell Health

    Lake Success, New York, 11042

    Recruiting

  • Cedars Sinai

    Los Angeles, California, 90048

    Recruiting

  • Baptist Memorial Hospital Cancer Center

    Memphis, Tennessee, 38120

    Active, not recruiting

  • Sarah Cannon Research Institute - Nashville

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Yale New Haven Hospital, Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Active, not recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Terminated

  • Providence Cancer Institute

    Portland, Oregon, 97123

    Recruiting

  • Mayo Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Active, not recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Withdrawn

  • University of Arizona Cancer Center

    Tucson, Arizona, 85721

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20057

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Quirón Barcelona

    Barcelona, 08023

    Recruiting

  • START Rioja

    Logroño, 26006

    Recruiting

  • MD Anderson

    Madrid, 28033

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Regional de Málaga

    Málaga, 29011

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

  • Centro di Riferimento Oncologico (CRO Aviano)

    Aviano, 33081

    Recruiting

  • Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)

    Meldola, 47014

    Recruiting

  • Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043

    Recruiting

  • S.C. Oncologia Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Servizio Sanitario Regionale Emilia-Romagna-Azienda Unita Sanitaria Locale della Romagna - Ospedale Santa Maria delle Croci

    Ravenna, 48100

    Recruiting

  • IRCCS Istituti Fisioterapici Ospitalieri IFO

    Roma, 00144

    Recruiting

Other trials in Italy

Georgia4 sites, 4 recruiting

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

    Recruiting

  • Caraps Medline, Ltd (JSC VIAN)

    Tbilisi, 0159

    Recruiting

  • Institute of Clinical Oncology (ICO)

    Tbilisi, 0159

    Recruiting

  • Israel Georgian Medical Research Clinic Healthycore

    Tbilisi, 0159

    Recruiting

Other trials in Georgia

Ireland4 sites, 4 recruiting

  • START Dublin

    Dublin, 07

    Recruiting

  • St. James Hospital

    Dublin, 08

    Recruiting

  • Beaumont Hospital

    Dublin, 09

    Recruiting

  • University Hospital Galway

    Galway, H91 YR71

    Recruiting

Other trials in Ireland

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne, ul. Dębinki 7, 80-952 Gdańsk, Poland

    Gdansk, 80-214

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

    Recruiting

  • Warmińsko-Mazurskie Centrum Chorób Płuc

    Olsztyn, 10-357

    Recruiting

Other trials in Poland

About this study

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

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.

Read the detailed description

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.

Being tested
STK-012, pembrolizumab KEYTRUDA®, pemetrexed, carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STK-012Drug

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

  • pembrolizumab KEYTRUDA®Drug

    anti-PD-1 monoclonal antibody

  • pemetrexedDrug

    chemotherapy

  • carboplatinDrug

    chemotherapy

Study groups in NCT05098132
Study groupRoleWhat they receive
Phase 1a: STK-012 monotherapy dose escalationExperimentalSTK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
Receives: Drug: STK-012
Phase 1a: STK-012 + pembrolizumab dose escalationExperimentalSTK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®
Phase 1a: STK-012 + standard of care (SoC) dose escalationExperimentalSTK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
Phase 1b: STK-012 monotherapy expansionExperimentalSTK-012 SC monotherapy in selected solid tumor indications
Receives: Drug: STK-012
Phase 1b: STK-012 + pembrolizumab dose expansionExperimentalSTK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®
Phase 1b: STK-012 + SoC dose expansionExperimentalSTK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
Phase 2: Arm AExperimentalSTK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
Phase 2: Arm BExperimentalSTK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Receives: Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
Phase 2: Arm CActive comparatorSoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
Receives: Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence of TEAEs in participants with select advanced solid tumors

    Measured: From 1st dose of study treatment through 90 days after last dose

  2. Phase 1a: Serious adverse events (SAEs)

    Incidence of SAEs in participants with select advanced solid tumors

    Measured: From 1st dose of study treatment through 90 days after last dose

  3. Phase 1a: Dose limiting toxicities (DLTs)

    Incidence of DLTs in participants with select advanced solid tumors

    Measured: Cycle 1, Days 1 through 21

  4. Phase 1a: Deaths

    Incidence of death in participants with select advanced solid tumors

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

  5. Phase 1b: TEAEs at the RP2D

    Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors

    Measured: From 1st dose of study treatment through 90 days after last dose

  6. Phase 1b: SAEs at the RP2D

    Incidence of SAEs at the RP2D in participants with select advanced solid tumors

    Measured: From 1st dose of study treatment through 90 days after last dose

  7. Phase 1b: Deaths at the RP2D

    Incidence of death at the RP2D in participants with select advanced solid tumors

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

  8. Phase 2: Overall response rate (ORR) in Arm A versus Arm C

    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.

    Measured: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

Secondary outcomes (16)

  1. Phase 1: ORR

    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.

    Measured: From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

  2. Phase 1: Progression free survival (PFS)

    Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors.

    Measured: From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years

  3. Phase 1: Overall survival (OS)

    Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors.

    Measured: From enrollment until death due to any cause, up to 4 years

  4. Phase 1/2: STK-012 ADAs

    Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors.

    Measured: From screening through 30 days after last dose of STK-012

  5. Phase 1/2: AUC of STK-012

    Area under the curve (AUC) to assess pharmacokinetic (PK) characterization of STK-012 in advanced NSCLC and other select solid tumors.

    Measured: From screening through 30 days after last dose of STK-012

  6. Phase 1/2: Cmax of STK-012

    Maximum concentration (Cmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

    Measured: From screening through 30 days after last dose of STK-012

  7. Phase 1/2: Tmax of STK-012

    Time of maximum concentration (Tmax) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

    Measured: From screening through 30 days after last dose of STK-012

  8. Phase 1/2: Half life of STK-012

    Half life (t1/2) to assess PK characterization of STK-012 in advanced NSCLC and other select solid tumors.

    Measured: From screening through 30 days after last dose of STK-012

  9. Phase 2: PFS in Arm A versus Arm C

    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.

    Measured: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years

  10. Phase 2: ORR in Arm B versus Arm C

    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.

    Measured: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

  11. Phase 2: PFS in Arm B versus Arm C

    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.

    Measured: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years

  12. Phase 2: OS in Arm A versus C

    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.

    Measured: From randomization until death due to any cause, up to 4 years

  13. Phase 2: OS in Arm B versus C

    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.

    Measured: From randomization until death due to any cause, up to 4 years

  14. Phase 2: TEAEs

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

    Measured: From 1st dose of study treatment through 90 days after last dose

  15. Phase 2: SAEs

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

    Measured: From 1st dose of study treatment through 90 days after last dose

  16. Phase 2: Deaths

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start25 Jan 2022
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098132
Sponsor's protocol ID
STK-012-101
Other IDs
2025-522632-14-00, KEYNOTE-G63, MK-3475-G63, 2025
Acronym
SYNERGY-101
Status last verified
Jun 2026
First submitted
6 Oct 2021
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STK-012, pembrolizumab KEYTRUDA® and pemetrexed in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Synthekine at 60 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Spain, Italy, Georgia, Ireland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Synthekine STK-012-101 Contact (650-606-6319, STK-012-101.contact@synthekine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Treatment emergent adverse events (TEAEs) (time frame: From 1st dose of study treatment through 90 days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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