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First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06797999•Adcendo ApS

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (8)

University of Colorado Denver

Aurora, Colorado, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Of Texas MD Anderson Cancer Center

Houston, Texas, United States

Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg

Leuven, Belgium

Centre Léon Bérard

Lyon, France

Universitätsklinikum Essen West German Tumor Center

Essen, Germany

Royal Marsden

London, United Kingdom

Key Dates

Start Date

June 5, 2025

Primary Completion Date

February 27, 2029

Completion Date

February 27, 2029

Last Updated

January 28, 2026

Enrollment

270

ESTIMATED participants

Conditions

Metastatic Soft Tissue SarcomaUnresectable Soft Tissue Sarcoma

Interventions

Antibody-drug conjugate (ADC)

BIOLOGICAL

Contacts

René Smrčka

CONTACT

+45 3144 0653 rene.smrcka@adcendo.com

Margaret McNaull

CONTACT

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

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

NCT03138161

Advanced Soft Tissue SarcomaMetastatic Soft Tissue Sarcoma

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ACTIVE_NOT_RECRUITINGPHASE2

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

NCT04200443

Metastatic LeiomyosarcomaMetastatic Soft Tissue Sarcoma+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

Phase II Study of Regorafenib as Maintenance Therapy

Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma