First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

NCT06797999 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: ADCE-D01-0012024-516900-41-00
• Study Type: interventional
• Target: 270
• Locations: 5 countries
• Sites: 8

Brief Summary

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

Conditions

Unresectable Soft Tissue Sarcoma; Metastatic Soft Tissue Sarcoma

Keywords

Phase 1/Phase 2; Sequential; Treatment

Outcome Measures

Primary Outcomes (2)

• Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.

  Measuring incidence of dose-limiting toxicities (DLTs)

  From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)

• Assess the safety and tolerability of ADCE-D01

  Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Secondary Outcomes (8)

• Maximum concentration (Cmax)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• ADCE-D01 time to Cmax (Tmax)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• ADCE-D01 area under the concentration-time curve (AUC)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Evaluate ADCE-D01 objective response rate (ORR)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Evaluate ADCE-D01 duration of response (DOR)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Study Arms (1)

ADCE-D01

OTHER

ADCE-D01

Biological: Antibody-drug conjugate (ADC)

Interventions

Antibody-drug conjugate (ADC) BIOLOGICAL

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.

Also known as: ADCE-D01

ADCE-D01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adcendo ApS: lead

Study Sites (8)

University of Colorado Denver

Aurora, Colorado, 80208, United States

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Universitätsklinikum Essen West German Tumor Center

Essen, D-45147, Germany

RECRUITING

Royal Marsden

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Immunoconjugates

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

René Smrčka

CONTACT

+45 3144 0653; rene.smrcka@adcendo.com

Margaret McNaull

CONTACT

+44 7818 457619.; margaret.mcnaull@adcendo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): February 27, 2029
• Study Completion (Estimated): February 27, 2029
• Last Updated: January 28, 2026

Record last verified: 2025-05

Locations

BE (1); FR (1); DE (1); GB (1); US (4)