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Brief Title: STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

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

INTRODUCTION

  • Org Study ID: STK-012-101
  • Secondary ID: N/A
  • NTC ID: NCT05098132
  • Sponsor: Synthekine

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.

  • Overall Status
    Recruiting
  • Start Date
    January 25, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: 1 cycle (21 days)

Primary Outcome 2 - Measure: Adverse events

Primary Outcome 2 - Timeframe: From 1st dose of STK-012 through 90 days after last dose of STK-012

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
  • Gastric Cancer
  • GastroEsophageal Cancer
  • Urothelial Carcinoma
  • Mismatch Repair Deficiency

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 650.271.9888

Email: clinicaltrialinfo@synthekine.com

LOCATION

Facility Status Contact
Facility: Columbia University Irving Medical Center
New York, New York 10032
United States
Status: Recruiting Contact: Contact
Nurse Navigator
212-342-5162
cancerclinicaltrials@cumc.columbia.edu
Facility: Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Dmitriy Zamarin, MD
412-623-6028
ZamarinD@mskcc.org
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Sarah Behr
210-580-9500
behrse@upmc.edu
Facility: Sarah Cannon Research Institute - Nashville
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Frances Gatlin, BSN, RN

DDUreferrals@sarahcannon.com
Facility: NEXT Virginia
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact


fgatlin@nextoncology.com