Actively Recruiting
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
Led by Simcha IL-18, Inc. · Updated on 2024-11-15
316
Participants Needed
6
Research Sites
229 weeks
Total Duration
On this page
Sponsors
S
Simcha IL-18, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
CONDITIONS
Official Title
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 2 years or older
- Written informed consent provided
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor
- For Phase 1a, allowed tumors include melanoma, Merkel cell, renal cell carcinoma, urothelial, non-small cell lung cancer, triple-negative breast cancer, squamous cell carcinoma of the head and neck, MSI-Hi tumors, high tumor mutation burden, mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma, and platinum resistant ovarian cancer
- Disease progression after standard therapy or no suitable standard care therapy available
- For Phase 1 combination therapy, allowed tumors include melanoma, Merkel cell, renal cell carcinoma, urothelial, non-small cell lung cancer without EGFR, TRK receptor, or ALK mutations/fusions, triple-negative breast cancer, squamous cell carcinoma of the head and neck, MSI-Hi tumors, high tumor mutation burden, mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, and hepatocellular carcinoma
- For Phase 2, allowed tumors include melanoma, renal cell carcinoma, triple-negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and MSI-Hi tumors
- At least one measurable lesion per RECIST 1.1 criteria which has not been biopsied or previously irradiated
- Accessible tumor suitable for biopsy before and during treatment (mandatory)
You will not qualify if you...
- History of another malignancy
- Symptomatic brain metastases requiring more than 10 mg/day prednisolone or equivalent
- Significant cardiovascular disease or ECG abnormalities
- Any degree of respiratory compromise
- Ongoing systemic bacterial, fungal, or viral infection
- Received a live vaccine within 30 days
- Major surgery within 4 weeks
- Prior organ or bone marrow transplantation
- Prior high-dose chemotherapy requiring stem cell rescue
- History of active autoimmune disorders
- Ongoing immunosuppressive therapy, including corticosteroids
- Received systemic anticancer therapy or investigational agent within 4 weeks before study
- Positive SARS-CoV-2 test within 28 days before dosing without clinical recovery
- Adrenal insufficiency
- Laboratory values of Grade 2 or higher
- For Phase 1 combination only: active CNS metastases or carcinomatous meningitis, recent radiotherapy or radiation pneumonitis, active autoimmune disease requiring systemic treatment in past 2 years, prior anti-PD-1/PD-L1 therapy discontinued due to severe immune-related adverse events, severe hypersensitivity to pembrolizumab, history or current pneumonitis/interstitial lung disease, lung radiation over 30Gy within 6 months before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
B
Beatrice McQueen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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