Back to resultsPhase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
Primary Purpose
Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STK-012
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor
Eligibility Criteria
Selected Inclusion Criteria
- 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
- 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.
- Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
Selected Exclusion Criteria:
- 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.
- 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.
- Received prior IL-2-based or IL-15-based cytokine therapy
Sites / Locations
- Massachusetts General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Columbia University Irving Medical CenterRecruiting
- Memorial Sloan-Kettering Cancer CenterRecruiting
- Duke Cancer CenterRecruiting
- UPMC Hillman Cancer CenterRecruiting
- Sarah Cannon Research Institute - NashvilleRecruiting
- NEXT VirginiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A: STK-012 weekly (QW) monotherapy dose escalation
Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
Part C: STK-012 Q3W + pembrolizumab dose escalation
Part D: Dose expansions
Arm Description
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
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.
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.
Outcomes
Primary Outcome Measures
Dose limiting toxicities (DLTs)
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
Adverse events
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
Objective response rate (ORR)
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
Progression-free survival (PFS)
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
Overall Survival (OS)
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
Area under the curve (AUC) 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
Maximum concentration (Cmax) 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
Time of maximum concentration (Tmax) 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
Half-life (T1/2) 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
Immunogenicity
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05098132
Brief Title
Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthekine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part A: STK-012 weekly (QW) monotherapy dose escalation
Arm Type
Experimental
Arm Description
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.
Arm Title
Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
Arm Type
Experimental
Arm Description
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Arm Title
Part C: STK-012 Q3W + pembrolizumab dose escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Part D: Dose expansions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
STK-012
Intervention Description
pegylated alpha/beta-biased engineered interleukin-2
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
anti-PD-1 humanized monoclonal antibody
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLTs)
Description
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
Time Frame
1 cycle (21 days)
Title
Adverse events
Description
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.
Time Frame
From 1st dose of STK-012 through 90 days after last dose of STK-012
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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
Time Frame
Up to 24 months
Title
Progression-free survival (PFS)
Description
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
Time Frame
Up to 24 months
Title
Overall Survival (OS)
Description
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
Time Frame
Up to 24 months
Title
Area under the curve (AUC) of STK-012
Description
The AUC of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab
Time Frame
From 1st dose of STK-012 through 30 days after last dose of STK-012
Title
Maximum concentration (Cmax) of STK-012
Description
The Cmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab
Time Frame
From 1st dose of STK-012 through 30 days after last dose of STK-012
Title
Time of maximum concentration (Tmax) of STK-012
Description
The Tmax of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab
Time Frame
From 1st dose of STK-012 through 30 days after last dose of STK-012
Title
Half-life (T1/2) of STK-012
Description
The T1/2 of STK-012 will be measured at different timepoints after STK-012 administration as monotherapy and in combination with pembrolizumab
Time Frame
From 1st dose of STK-012 through 30 days after last dose of STK-012
Title
Immunogenicity
Description
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
Time Frame
From 1st dose of STK-012 through 30 days after last dose of STK-012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Selected Inclusion Criteria
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
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.
Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
Selected Exclusion Criteria:
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.
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.
Received prior IL-2-based or IL-15-based cytokine therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
650-271-9888
Email
clinicaltrialinfo@synthekine.com
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Sullivan, MD
Phone
617-724-4000
Email
rsullivan7@mgh.harvard.edu
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Childs, NP
Email
achilds1@bidmc.harvard.edu
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Jones, NP
Phone
857-215-1351
Email
Carolyn_jones@dfci.harvard.edu
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurse Navigator
Phone
212-342-5162
Email
cancerclinicaltrials@cumc.columbia.edu
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitriy Zamarin, MD
Email
ZamarinD@mskcc.org
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-681-6468
Email
CCI-TrialReferrals@duke.edu
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Behr
Phone
412-623-6028
Email
behrse@upmc.edu
Facility Name
Sarah Cannon Research Institute - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
DDUreferrals@sarahcannon.com
Facility Name
NEXT Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Gatlin, BSN, RN
Phone
210-580-9500
Email
fgatlin@nextoncology.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
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