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 12, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Arm | Intervention/treatment |
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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.
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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 |
- 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 RP2D of STK-012 as a single agent and in combination with pembrolizumab
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Selected Inclusion Criteria
- Patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
- Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated.
- 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 radiotherapy within 2 weeks of the first dose of study treatment.
- Received prior IL-2-based or IL-15-based cytokine therapy.
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
Contact: Clinical Operations | 650-271-9888 | clinicaltrialinfo@synthekine.com |
United States, California | |
UC San Diego Moores Cancer Center | Recruiting |
La Jolla, California, United States, 92093-0698 | |
Contact: Rana McKay, MD 858-822-5522 rmckay@health.ucsd.edu | |
Contact: Karen Cuervo 858-822-7952 kcuervo@health.ucsd.edu | |
UCLA Hematology/Oncology - Santa Monica | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Tina Tieu 310-633-8400 TinaTieu@mednet.ucla.edu | |
United States, Connecticut | |
Yale New Haven Hospital, Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Jialing Zhang, PhD 475-234-9684 jialing.zhang@yale.edu | |
United States, Georgia | |
Winship Cancer Institute, Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Marsha Sterling marsha.harris@emory.edu | |
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: Adam Schoenfeld, MD schoenfa@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 |
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 12, 2024 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 Skin Neoplasms |
Skin Diseases 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 |