Actively Recruiting
Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Adults With Refractory Solid Tumors Including Sarcoma
Led by EpicentRx, Inc. · Updated on 2024-10-26
140
Participants Needed
6
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying AdAPT-001, an oncolytic virus, in people with advanced sarcoma and other refractory solid tumors. The study aims to assess if AdAPT-001 is safe and tolerable when injected directly into tumors and to evaluate its effectiveness alone or combined with a checkpoint inhibitor. This research includes multiple parts, each focusing on different doses and treatment combinations to better understand how this therapy works in cancer patients. The study has several phases. Initially, patients received a single injection of AdAPT-001 to find a safe dose. Later phases involved giving injections on Days 1 and 15 of each 28-day cycle, up to 12 injections. Some participants receive only AdAPT-001, while others may also receive a checkpoint inhibitor based on their condition. The trial includes an open Phase 2 where patients with confirmed sarcoma or other advanced solid tumors participate in one of two treatment arms. Participants will have their tumors injected with AdAPT-001 and may also receive checkpoint inhibitors. Researchers will monitor safety, tolerability, and anti-tumor activity through laboratory tests and clinical assessments over six months. Key outcomes include dose-limiting toxicities, maximum tolerated dose, and tumor response. The study involves regular evaluations to track effects and side effects, with total participation time varying by treatment stage.
CONDITIONS
Brief 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 the study and provide written informed consent
- Male or female aged 18 years or older
- Confirmed diagnosis of advanced malignant solid tumor with a tumor accessible for treatment
- ECOG performance status of 0 or 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 less than 1.5 times the upper limit of normal
- Acceptable blood counts (neutrophils > 1,500 cells/mm3; platelets > 75,000/mm3; hemoglobin ≥ 8.0 g/dL)
- INR less than 1.5
- Agree to use medically acceptable contraception if of childbearing potential
- Willing and able to follow all study procedures and evaluations
- Optional: Provide archival tumor tissue if available
You will not qualify if you...
- Serious co-morbid medical conditions or untreated systemic disorders
- Active uncontrolled bacterial, fungal, or viral infections, including recent COVID-19
- Known positive HIV test
- Active hepatitis infection
- Pregnancy or breastfeeding
- Active or history of autoimmune disease that affects vital organs or requires immunosuppressive treatment
- Recent treatment with systemic corticosteroids or immunosuppressive agents within 14 days before study
- Prior adenoviral therapy except for vaccination
- Recent chemotherapy or immunotherapy within 14 days before study treatment
- Concurrent use of certain medications unless allowed (e.g., hormonal therapy, bisphosphonates)
Research Team
J
Jeannie Williams
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