Clinical trial NCT05098132: STK-012 Monotherapy and in Combination Therapy in Patients With Solid Tumors
Official title: A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Patients With Selected Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Synthekine
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 therapy in patients with selected advanced solid tumors.

Detailed description: The phase 1a portion of the study is a dose escalation design to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.

Eligibility criteria: Selected Inclusion Criteria:

1. Participants enrolled to STK-012 monotherapy dose escalation and expansion and STK-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
2. Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease.
3. Participants enrolled to STK-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have NSCLC and may not have received treatment for metastatic disease.
4. Participants enrolled to STK-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have PD-L1 negative NSCLC and may not have received treatment for metastatic disease.

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 radiotherapy within 2 weeks of the first dose of study treatment.
3. Received prior IL-2-based or IL-15-based cytokine therapy.
4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.

Primary outcomes:
measure: Dose limiting toxicities (DLTs)
timeFrame: 1 cycle (21 days)
measure: Adverse events
timeFrame: From 1st dose of STK-012 through 90 days after last dose of STK-012
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
measure: Area under the curve (AUC) of STK-012
timeFrame: From 1st dose of STK-012 through 30 days after last dose of STK-012
measure: Maximum concentration (Cmax) of STK-012
timeFrame: From 1st dose of STK-012 through 30 days after last dose of STK-012
measure: Time of maximum concentration (Tmax) of STK-012
timeFrame: From 1st dose of STK-012 through 30 days after last dose of STK-012
measure: Half-life (T1/2) of STK-012
timeFrame: From 1st dose of STK-012 through 30 days after last dose of STK-012
measure: Immunogenicity
timeFrame: From 1st dose of STK-012 through 30 days after last dose of STK-012
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital, Yale Cancer Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York City
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - Nashville
state: Tennessee
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
Study officials:
References: