Testing a new treatment for soft tissue sarcoma
A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
This study is testing a new treatment called ADCE-D01 to see if it can help people with advanced soft tissue sarcoma feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adcendo ApS Industry-sponsored |
| Locations | 8 sites (Aurora, Colorado and 7 other locations) |
| Trial ID | NCT06797999 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety, tolerability, and efficacy of a novel antibody-drug conjugate called ADCE-D01 in patients with metastatic or unresectable soft tissue sarcoma. The study will assess the incidence of dose-limiting toxicities (DLTs) to determine safety, while efficacy will be measured through various endpoints such as overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), clinical benefit rate (CBR), and time to response (TTR) according to RECIST v1.1 criteria. The trial is designed in two phases, allowing for a comprehensive evaluation of the treatment's effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed metastatic or unresectable soft tissue sarcoma who have received one to two prior lines of cytotoxic therapy.
Not a fit: Patients with resectable soft tissue sarcoma or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced soft tissue sarcoma who have limited treatment alternatives.
How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results in treating various cancers, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 7 other locations
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University Of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven, Belgium (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Universitätsklinikum Essen West German Tumor Center — Essen, Germany (Recruiting)
- Royal Marsden — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: René Smrčka
- Email: rene.smrcka@adcendo.com
- Phone: +45 3144 0653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.