NCT06797999 · Adcendo ApS
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
(ADCElerate1)
What this study is about
The goal of this clinical trial is to learn about the safety, tolerability and effectiveness of ADCE-D01.
View original scientific description
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Interventions
BIOLOGICAL
Antibody-drug conjugate (ADC)
ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.
Primary outcome measures
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
Time frame: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
Measuring incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-D01
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years of age 2. Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent). 3. Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease. 4. Measurable disease as per RECIST v 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy of at least 3 months. 7. 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 with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate. 8. 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 guida
Where
- Aurora, Colorado
- Miami, Florida
- New York, New York
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations