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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
  • NCT 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 candidate 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:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • 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

ELIGIBILITY

Selected Inclusion Criteria
1. Patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.

- 2. Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated.

- 3. Patients with central nervous system (CNS) metastases must have been treated and be asymptomatic.
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.

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: Clinical Operations

Phone: 650-271-9888

Email: clinicaltrialinfo@synthekine.com

LOCATION

Facility Status Contact
Facility: UC San Diego Moores Cancer Center
La Jolla, California 92093-0698
United States
Status: Recruiting Contact: Contact
Rana McKay, MD
858-822-5522
rmckay@health.ucsd.edu

Contact
Karen Cuervo
858-822-7952
kcuervo@health.ucsd.edu

Facility: UCLA Hematology/Oncology - Santa Monica
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
Tina Tieu
310-633-8400
TinaTieu@mednet.ucla.edu

Facility: Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut 06510
United States
Status: Recruiting Contact: Contact
Jialing Zhang, PhD
475-234-9684
jialing.zhang@yale.edu

Facility: Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Marsha Sterling
marsha.harris@emory.edu

Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Ryan Sullivan, MD
617-724-4000
rsullivan7@mgh.harvard.edu

Facility: Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Alexandra Childs, NP
achilds1@bidmc.harvard.edu

Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Carolyn Jones, NP
857-215-1351
Carolyn_jones@dfci.harvard.edu

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
Adam Schoenfeld, MD
schoenfa@mskcc.org

Facility: Duke Cancer Center
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact

919-681-6468
CCI-TrialReferrals@duke.edu

Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Sarah Behr
412-623-6028
behrse@upmc.edu

Facility: Sarah Cannon Research Institute - Nashville
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact

DDUreferrals@sarahcannon.com

Facility: NEXT Virginia
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Frances Gatlin, BSN, RN
210-580-9500
fgatlin@nextoncology.com