Testing a new treatment for soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: René Smrčka
• Email: rene.smrcka@adcendo.com
• Phone: +45 3144 0653

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding abemaciclib to gemcitabine chemotherapy for advanced soft tissue sarcoma

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  Recruiting Phase 1/2 National Cancer Institute (NCI) · Houston, Texas · NCT06498648

• Membrane-anchored IL-12–modified TIL (attIL12-TIL) therapy for advanced soft tissue and bone sarcoma

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  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT06474676

• Using pulmonary suffusion to control minimal residual disease in sarcoma and colorectal cancer patients

  This study is testing a new way to deliver chemotherapy directly to the lungs in patients with sarcoma or colorectal cancer that has spread there, to see if it helps control the disease better and is safe to use.

  Recruiting Phase 1/2 Roswell Park Cancer Institute · Buffalo, New York · NCT03965234

• Combination treatment for advanced soft tissue sarcoma

  This study is testing a new combination of treatments using Trabectedin, Ipilimumab, and Nivolumab to see if it can help people with advanced soft tissue sarcoma who have already received other treatments.

  Recruiting Phase 1/2 Sarcoma Oncology Research Center, LLC · Santa Monica, California · NCT03138161

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.