First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (ADCElerate1)

January 27, 2026 updated by: Adcendo ApS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
        • Contact:
          • Patrick Schöffski, Dr.
  • France
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Jean-Yves Blay, Prof.
  • Germany
      • Essen, Germany, D-45147
        • Recruiting
        • Universitätsklinikum Essen West German Tumor Center
        • Contact:
          • Sebastian Bauer, Dr.
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Royal Marsden
        • Contact:
          • Robin Jones, Dr.
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80208
        • Recruiting
        • University of Colorado Denver
        • Contact:
          • Breelyn Wilky, Dr.
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami - Sylvester Comprehensive Cancer Center
        • Contact:
          • Jonathan Trent, Dr.
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Robert Maki, Dr.
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Shreyaskumar Patel, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ADCE-D01
Biological: Antibody-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.
Other Names:
  • ADCE-D01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
Time Frame: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
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
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to maximum plasma concentration will be assessed to inform ADCE-D01 PK profile
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to Cmax (Tmax)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to Cmax (Tmax) will be assessed to characterize the ADCE-D01 PK profile
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 area under the concentration-time curve (AUC)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 area under the concentration-time curve (AUC) will be assessed to characterize PK profile
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 objective response rate (ORR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR) per RECIST v1.1 by Investigator assessment
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 duration of response (DOR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response DOR, measured per RECIST v1.1 by Investigator assessment will be used to further characterize the durability of tumor response of ADCE-D01
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 progression-free survival (PFS)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollmen
Progression-free survival (PFS) assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity.
Throughout the trial duration, completion expected approximately 18 months from completed enrollmen
ADCE-D01 clinical benefit rate (CBR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
clinical benefit rate (CBR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to response (TTR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
time to response (TTR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01
Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adcendo ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

February 27, 2029

Study Completion (Estimated)

February 27, 2029

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADCE-D01-001
  • 2024-516900-41-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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