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 |
Trial Parameters
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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 guidan