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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522632-14-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: STK-012 monotherapy dose escalation | Experimental | STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications |
|
| Phase 1a: STK-012 + pembrolizumab dose escalation | Experimental | STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications |
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| Phase 1a: STK-012 + standard of care (SoC) dose escalation | Experimental | STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC |
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| Phase 1b: STK-012 monotherapy expansion | Experimental | STK-012 SC monotherapy in selected solid tumor indications |
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| Phase 1b: STK-012 + pembrolizumab dose expansion | Experimental | STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STK-012 | Drug | Engineered Interleukin-2 (IL-2) selective for antigen activated T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Treatment emergent adverse events (TEAEs) | Incidence of TEAEs in participants with select advanced solid tumors | From 1st dose of study treatment through 90 days after last dose |
| Phase 1a: Serious adverse events (SAEs) | Incidence of SAEs in participants with select advanced solid tumors | From 1st dose of study treatment through 90 days after last dose |
| Phase 1a: Dose limiting toxicities (DLTs) | Incidence of DLTs in participants with select advanced solid tumors | Cycle 1, Days 1 through 21 |
| Phase 1a: Deaths | Incidence of death in participants with select advanced solid tumors | From 1st dose of study treatment until death, up to 4 years |
| Phase 1b: TEAEs at the RP2D | Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors | From 1st dose of study treatment through 90 days after last dose |
| Phase 1b: SAEs at the RP2D | Incidence of SAEs at the RP2D in participants with select advanced solid tumors | From 1st dose of study treatment through 90 days after last dose |
| Phase 1b: Deaths at the RP2D | Incidence of death at the RP2D in participants with select advanced solid tumors | From 1st dose of study treatment until death, up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Synthekine STK-012-101 Contact | Contact | 650-606-6319 | STK-012-101.contact@synthekine.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85721 | United States | |
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| Phase 1b: STK-012 + SoC dose expansion | Experimental | STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC |
|
| Phase 2: Arm A | Experimental | STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
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| Phase 2: Arm B | Experimental | STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
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| Phase 2: Arm C | Active Comparator | SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
|
| pembrolizumab KEYTRUDA® | Drug | anti-PD-1 monoclonal antibody |
|
| pemetrexed | Drug | chemotherapy |
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| carboplatin | Drug | chemotherapy |
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| 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. | From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years |
| Phase 1: Progression free survival (PFS) |
Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors. |
| From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years |
| Phase 1: Overall survival (OS) | Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors. | From enrollment until death due to any cause, up to 4 years |
| Phase 1/2: STK-012 ADAs | Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors. | From screening through 30 days after last dose of STK-012 |
| 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. | From screening through 30 days after last dose of STK-012 |
| 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. | From screening through 30 days after last dose of STK-012 |
| 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. | From screening through 30 days after last dose of STK-012 |
| 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. | From screening through 30 days after last dose of STK-012 |
| 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. | From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years |
| 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. | From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years |
| 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. | From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years |
| 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. | From randomization until death due to any cause, up to 4 years |
| 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. | From randomization until death due to any cause, up to 4 years |
| Phase 2: TEAEs | Incidence of TEAEs in 1L NSQ NSCLC (PD-L1<1% or STK11m) | From 1st dose of study treatment through 90 days after last dose |
| Phase 2: SAEs | Incidence of SAEs in 1L NSQ NSCLC (PD-L1<1% or STK11m) | From 1st dose of study treatment through 90 days after last dose |
| Phase 2: Deaths | Incidence of death in 1L NSQ NSCLC (PD-L1<1% or STK11m) | From 1st dose of study treatment until death, up to 4 years |
| Beverly Hills Cancer Center |
| Recruiting |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Providence Medical Foundation | Recruiting | Fullerton | California | 92835 | United States |
| UC San Diego Moores Cancer Center | Active, not recruiting | La Jolla | California | 92093-0698 | United States |
| Cedars Sinai | Recruiting | Los Angeles | California | 90048 | United States |
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
| UCLA Hematology/Oncology - Santa Monica | Recruiting | Santa Monica | California | 90404 | United States |
| Yale New Haven Hospital, Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20057 | United States |
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| HealthPartners Cancer Center at Regions Hospital | Recruiting | Saint Paul | Minnesota | 55101 | United States |
| Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Columbia University Irving Medical Center | Active, not recruiting | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Duke Cancer Center | Active, not recruiting | Durham | North Carolina | 27710 | United States |
| University Hospitals Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
| The James Cancer Hospital and Solove Research Institute | Recruiting | Columbus | Ohio | 43210 | United States |
| Providence Cancer Institute | Recruiting | Portland | Oregon | 97123 | United States |
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Hillman Cancer Center | Terminated | Pittsburgh | Pennsylvania | 15232 | United States |
| Baptist Memorial Hospital Cancer Center | Active, not recruiting | Memphis | Tennessee | 38120 | United States |
| Sarah Cannon Research Institute - Nashville | Active, not recruiting | Nashville | Tennessee | 37203 | United States |
| Renovatio Clinical | Withdrawn | El Paso | Texas | 79915 | United States |
| Oncology Consultants | Recruiting | Houston | Texas | 77303 | United States |
| Renovatio Clinical | Withdrawn | The Woodlands | Texas | 77380 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Northwest Medical Specialties | Active, not recruiting | Tacoma | Washington | 98405 | United States |
| LTD High Technology Hospital Medcenter | Recruiting | Batumi | 6000 | Georgia |
| Caraps Medline, Ltd (JSC VIAN) | Recruiting | Tbilisi | 0159 | Georgia |
| Institute of Clinical Oncology (ICO) | Recruiting | Tbilisi | 0159 | Georgia |
| Israel Georgian Medical Research Clinic Healthycore | Recruiting | Tbilisi | 0159 | Georgia |
| START Dublin | Recruiting | Dublin | 07 | Ireland |
| St. James Hospital | Recruiting | Dublin | 08 | Ireland |
| Beaumont Hospital | Recruiting | Dublin | 09 | Ireland |
| University Hospital Galway | Recruiting | Galway | H91 YR71 | Ireland |
| Hospital Quirón Barcelona | Recruiting | Barcelona | 08023 | Spain |
| START Rioja | Recruiting | Logroño | 26006 | Spain |
| MD Anderson | Recruiting | Madrid | 28033 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Regional de Málaga | Recruiting | Málaga | 29011 | Spain |
| Clinica Universidad de Navarra - Pamplona | Recruiting | Pamplona | 31008 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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