Actively Recruiting
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
Led by EpicentRx, Inc. · Updated on 2024-10-26
140
Participants Needed
6
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.
CONDITIONS
Official Title
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study purpose and risks and provide written consent
- Male or female aged 18 years or older
- Histologically or cytologically confirmed advanced malignant solid tumor
- Tumor accessible and/or palpable for treatment; ultrasound guidance allowed
- ECOG performance status 0-1 at screening
- Acceptable liver function: Bilirubin < 1.5 x ULN, AST and ALT < 3.0 x ULN, Alkaline Phosphatase < 2.5 x ULN
- Serum Creatinine < 1.5 x ULN
- Acceptable blood counts: Absolute neutrophil count > 1,500 cells/mm3, Platelet count > 75,000/mm3, Hemoglobin ≥ 8.0 g/dL
- INR < 1.5
- Agree to use effective contraception if of childbearing potential starting Study Day 1 until 4 weeks after last dose
- Willing and able to comply with all study procedures
- Optional archival tissue available if possible
You will not qualify if you...
- Serious co-morbid medical condition or lab findings suggesting infection or systemic disorder
- Uncontrolled active bacterial, fungal, or viral infection; no active COVID-19 infection within 14 days
- Known positive HIV test
- Active hepatitis
- Pregnant or breastfeeding females
- Active or history of autoimmune disease requiring immunosuppressive treatment
- Recent systemic corticosteroid use above specified doses within 14 days prior to treatment
- Prior adenoviral therapy except vaccination; restrictions around vaccinations
- Chemotherapy or immunotherapy within 14 days before study treatment (hormonal therapy allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
City of Hope
Duarte, California, United States, 91010
Active, Not Recruiting
2
California Cancer Associates for Research and Excellence, cCARE
San Marcos, California, United States, 92069
Active, Not Recruiting
3
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Active, Not Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Active, Not Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jeannie Williams
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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