NCT06797999 First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
| NCT ID | NCT06797999 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Adcendo ApS |
| Condition | Metastatic Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2029-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 270 participants in total. It began in 2025-06-05 with a primary completion date of 2029-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 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 guidance during the treatment period and for at least 7 months after last infusion of study treatment. Exclusion Criteria: 1. 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. 2. Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement. 3. Clinically significant cardiovascular disease 4. Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2. 5. Current active liver disease due to hepatitis B 6. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06797999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06797999 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06797999 currently recruiting?
Yes, NCT06797999 is actively recruiting participants. Contact the research team at rene.smrcka@adcendo.com for enrollment information.
Where is the NCT06797999 trial being conducted?
This trial is being conducted at Aurora, United States, Miami, United States, New York, United States, Houston, United States and 5 additional locations.
Who is sponsoring the NCT06797999 clinical trial?
NCT06797999 is sponsored by Adcendo ApS. The trial plans to enroll 270 participants.