TGF-β trap of AdAPT-001 turns up the heat on tumors and turns down checkpoint blocker resistance.
Tony R Reid, Bryan Oronsky, Jeannie Williams...
https://pubmed.ncbi.nlm.nih.gov/39461878Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04673942
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
Age: 18Years +
All Genders
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)
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 cycles of 28 days each
Participants receive intratumoral injections of AdAPT-001 on Days 1 and 15 of each 28-day cycle for up to 12 injections. Some participants may also receive a checkpoint inhibitor as part of their treatment based on their diagnosis and investigator discretion.
Biweekly visits on Days 1 and 15 of each 28-day cycle
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
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Research Team
J
Jeannie Williams
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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Published Research Related To This Trial
BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors.
Santosh Kesari, Alberto Bessudo, Brian R Gastman...
https://pubmed.ncbi.nlm.nih.gov/35950603