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New treatment option for Metastatic Soft Tissue Sarcoma
Official title First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT06797999
What this study is testing
What is Antibody-drug conjugate (ADC)?
Antibody-drug conjugate (ADC) is an investigational medicine, being studied as a potential treatment for metastatic soft tissue sarcoma.
Also referred to as ADCE-D01.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age
- Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
- Measurable disease as per RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to...
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
- Clinically significant cardiovascular disease
- Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
- Current active liver disease due to hepatitis B
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis...
See the full eligibility criteria
- ≥ 18 years of age
- Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
- Measurable disease as per RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients...
- A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months...
- Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
- Clinically significant cardiovascular disease
- Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
- Current active liver disease due to hepatitis B
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami, Florida, United States
- New York, New York, United States
- Houston, Texas, United States
- Leuven, Belgium
- Lyon, France
- Essen, Germany
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami, Florida, United States; New York, New York, United States; Houston, Texas, United States; Leuven, Belgium; Lyon, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.