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

  • STATUS
    Recruiting
  • End date
    Mar 17, 2026
  • participants needed
    135
  • sponsor
    Synthekine
Updated on 17 May 2022
monoclonal antibodies
interleukin-2
pembrolizumab
interleukin 2

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.

Description

The phase 1a portion of the study will evaluate STK-012 monotherapy administered subcutaneously weekly alone and in combination with pembrolizumab administered every 3 weeks intravenously in a standard 3+3 dose-escalation study design. Patients with selected solid tumor types will be enrolled who have progressed after standard of care treatments. The phase 1b dose expansion will evaluate STK-012 at the recommended phase 2 dose in combination with pembrolizumab in selected solid tumor types.

Details
Condition Advanced Solid Tumor, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Ovarian Cancer, Cervical Cancer, Microsatellite Instability High
Treatment Pembrolizumab, STK-012
Clinical Study IdentifierNCT05098132
SponsorSynthekine
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

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

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 (< 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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