Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06797999Sponsor: Adcendo ApSLast updated: 2026-01-28

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.

Arms & 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.

Outcome measures

Primary

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

    Measuring incidence of dose-limiting toxicities (DLTs)

    Time frame: 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.

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

Secondary

  • Maximum concentration (Cmax)

    Time frame: 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

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

    Time frame: 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

  • Evaluate ADCE-D01 duration of response (DOR)

    Time frame: 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

  • ADCE-D01 clinical benefit rate (CBR)

    Time frame: 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

University of Colorado Denver

Aurora, Colorado, 80208

Recruiting
Breelyn Wilky, Dr. · Contact

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Jonathan Trent, Dr. · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Robert Maki, Dr. · Contact

University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Shreyaskumar Patel, Dr. · Contact