Actively Recruiting
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Led by Adcendo ApS · Updated on 2026-01-28
270
Participants Needed
8
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
CONDITIONS
Official Title
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed soft tissue sarcoma with metastatic and/or unresectable disease
- Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease
- Measurable disease according to RECIST v 1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Male patients must agree to use barrier contraception during treatment and for 4 months after last infusion and refrain from donating sperm during this period
- Male patients with pregnant partners must use barrier contraception or abstain from sexual activity during treatment and for 4 months after last infusion
- Female patients must not be pregnant, breastfeeding, or be women of childbearing potential unless agreeing to use contraception during treatment and for 7 months after last infusion
You will not qualify if you...
- Systemic anticancer therapy, including investigational agents, within 4 weeks or 5 half-lives before study treatment
- Primary brain malignancy or untreated central nervous system or leptomeningeal metastases, or symptoms suggesting CNS involvement
- Clinically significant cardiovascular disease
- Acute HIV 1 or HIV 2 infection
- 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 chest CT scan at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Colorado Denver
Aurora, Colorado, United States, 80208
Actively Recruiting
2
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
6
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
7
Universitätsklinikum Essen West German Tumor Center
Essen, Germany, D-45147
Actively Recruiting
8
Royal Marsden
London, United Kingdom
Not Yet Recruiting
Research Team
R
René Smrčka
CONTACT
M
Margaret McNaull
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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