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Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05098132
Recruitment Status : Recruiting
First Posted : October 28, 2021
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Synthekine

Study Description
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Brief Summary:
This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Malignant Melanoma Renal Cell Carcinoma Cervical Cancer Microsatellite Instability High Gastric Cancer GastroEsophageal Cancer Urothelial Carcinoma Mismatch Repair Deficiency Drug: STK-012 Drug: Pembrolizumab Phase 1

Detailed Description:
The phase 1a portion of the study is standard 3+3 dose escalation design to evaluate STK-012 as monotherapy and in combination with pembrolizumab in patients with selected solid tumors who have progressed after standard of care treatments. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination with pembrolizumab at the recommended phase 2 dose (RP2D) in selected solid tumor types.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
Actual Study Start Date : January 25, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: STK-012 weekly (QW) monotherapy dose escalation
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.
 Drug: STK-012
pegylated alpha/beta-biased engineered interleukin-2
Experimental: Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
 Drug: STK-012
pegylated alpha/beta-biased engineered interleukin-2
Experimental: Part C: STK-012 Q3W + pembrolizumab dose escalation
STK-012 will be administered in sequential ascending doses SC Q3W in combination with a fixed dose of pembrolizumab intravenously (IV) Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
 Drug: STK-012
pegylated alpha/beta-biased engineered interleukin-2

Drug: Pembrolizumab
anti-PD-1 humanized monoclonal antibody
Experimental: Part D: Dose expansions
STK-012 will be administered at the RP2D SC as monotherapy and in combination with a fixed dose of pembrolizumab IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
 Drug: STK-012
pegylated alpha/beta-biased engineered interleukin-2

Drug: Pembrolizumab
anti-PD-1 humanized monoclonal antibody


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicities (DLTs) [ Time Frame: 1 cycle (21 days) ]
    Incidence of adverse events (AEs) meeting protocol defined DLT criteria and determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of STK-012 as a single agent and in combination with pembrolizumab

  2. Adverse events [ Time Frame: From 1st dose of STK-012 through 90 days after last dose of STK-012 ]
    Assess the safety and tolerability of STK-012 as monotherapy and in combination with pembrolizumab by review of AEs including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, and adverse events resulting in death.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
    The ORR is defined as the proportion of patients with confirmed CR or confirmed PR, based on RECIST Version 1.1 after STK-012 administration as monotherapy and in combination with pembrolizumab

  2. Progression-free survival (PFS) [ Time Frame: Up to 24 months ]
    PFS is defined as the time from the start of treatment with STK-012 until the first documentation of disease progression or death due to any cause, whichever occurs first after STK-012 administration as monotherapy and in combination with pembrolizumab

  3. Overall Survival (OS) [ Time Frame: Up to 24 months ]
    Overall survival is defined as the time from the start of treatment with STK-012 until death due to any cause after STK-012 administration as monotherapy and in combination with pembrolizumab

  4. Area under the curve (AUC) of STK-012 [ Time Frame: From 1st dose of STK-012 through 30 days after last dose of STK-012 ]
    The AUC of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab

  5. Maximum concentration (Cmax) of STK-012 [ Time Frame: From 1st dose of STK-012 through 30 days after last dose of STK-012 ]
    The Cmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab

  6. Time of maximum concentration (Tmax) of STK-012 [ Time Frame: From 1st dose of STK-012 through 30 days after last dose of STK-012 ]
    The Tmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab

  7. Half-life (T1/2) of STK-012 [ Time Frame: From 1st dose of STK-012 through 30 days after last dose of STK-012 ]
    The T1/2 of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab

  8. Immunogenicity [ Time Frame: From 1st dose of STK-012 through 30 days after last dose of STK-012 ]
    The immunogenicity of STK-012 will be assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Selected Inclusion Criteria

  1. In dose-escalation (Phase 1a), patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment
  2. Available archived tumor tissue sample. In the setting where archival material is unavailable or unsuitable for use, the patient must consent and undergo fresh tumor biopsy. In some patients, a new pre-treatment and on-treatment tumor biopsy may be required.
  3. Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.

Selected Exclusion Criteria:

  1. Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
  2. Received definitive radiotherapy within 2 weeks of the first dose of study treatment; or palliative radiotherapy (defined as < 2 weeks of radiotherapy to non-central nervous system [CNS] disease) within 1 week of the first dose of study treatment.
  3. Received prior IL-2-based or IL-15-based cytokine therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098132


Contacts
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Contact: Clinical Operations 650-271-9888 clinicaltrialinfo@synthekine.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Sullivan, MD    617-724-4000    rsullivan7@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alexandra Childs, NP       achilds1@bidmc.harvard.edu   
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Carolyn Jones, NP    857-215-1351    Carolyn_jones@dfci.harvard.edu   
United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Nurse Navigator    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dmitriy Zamarin, MD       ZamarinD@mskcc.org   
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact    919-681-6468    CCI-TrialReferrals@duke.edu   
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sarah Behr    412-623-6028    behrse@upmc.edu   
United States, Tennessee
Sarah Cannon Research Institute - Nashville Recruiting
Nashville, Tennessee, United States, 37203
Contact       DDUreferrals@sarahcannon.com   
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Frances Gatlin, BSN, RN    210-580-9500    fgatlin@nextoncology.com   
Sponsors and Collaborators
Synthekine
More Information
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Responsible Party: Synthekine
ClinicalTrials.gov Identifier: NCT05098132    
Other Study ID Numbers: STK-012-101
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Microsatellite Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma, Squamous Cell
 Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Head and Neck Neoplasms
Genomic Instability
Pathologic Processes
Pembrolizumab
Antineoplastic Agents, Immunological