First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdcendo ApS
About this trial
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Eligibility criteria
Qualifiers
≥ 18 years of age
Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
Measurable disease as per RECIST v 1.1.
Disqualifiers
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.
Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
Clinically significant cardiovascular disease
Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
Trial design
Treatments tested in this trial
- Antibody-drug conjugate (ADC)
Treatment groups
270 Participants
are divided into 1 treatment groupLocations
8Belgium
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg3000, Leuven Belgium
France
Centre Léon Bérard69373, Lyon France
Germany
Universitätsklinikum Essen West German Tumor CenterD-45147, Essen Germany
United Kingdom
Royal Marsden London United Kingdom
Sponsors and collaborators
Adcendo ApS
Lead sponsor
Source ClinicalTrials.gov