STK-012 Monotherapy and in Combination Therapy in Patients With Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05098132
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Synthekine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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, Untreated Advanced NSCLC, 1st Line NSCLC

Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

Experimental: Part D: STK-012 Q3W monotherapy and STK-012 Q3W + pembrolizumab 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.

Experimental: Part E: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose escalation

STK-012 will be administered in sequential ascending doses SC Q3W in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Experimental: Part F: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose expansion

STK-012 will be administered at the RP2D SC in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Interventions

Drug: - STK-012

pegylated alpha/beta-biased engineered interleukin-2

Drug: - pembrolizumab

anti-PD-1 humanized monoclonal antibody

Drug: - pemetrexed

antifolate chemotherapy

Drug: - carboplatin

platinum chemotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona Cancer Center, Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

University of Arizona Cancer Center

Tucson 5318313, Arizona 5551752, 85721

Site Contact

Mikayla Kirby

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