RecruitingPhase 1Phase 2NCT06797999

First-in-Human Study of ADCE-D01 in 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

Sponsor

Adcendo ApS

Enrollment

270 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Soft Tissue Sarcoma Unresectable Soft Tissue Sarcoma

Summary

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

≥ 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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 3 months.
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.
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 Criteria6

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.
Current active liver disease due to hepatitis B
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.

Interventions

BIOLOGICALAntibody-drug conjugate (ADC)

ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.