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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Adcendo ApS
Study ID
NCT06797999
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Jun 5, 2025
Status verified
May 2025
Primary completion
Feb 27, 2029
Completion
Feb 27, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: ADCE-D01
    ADCE-D01

Primary Outcome Measure

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) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80208
Breelyn Wilky, Dr.
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Jonathan Trent, Dr.
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Robert Maki, Dr.
University Of Texas MD Anderson Cancer CenterHoustonTexas77030
Shreyaskumar Patel, Dr.

Find similar trials in Aurora, CO

By research site
University of Colorado Denver· Aurora, COUniversity of Miami - Sylvester Comprehensive Cancer Center· Miami, FLMemorial Sloan Kettering Cancer Center· New York, NYUniversity Of Texas MD Anderson Cancer Center· Houston, TX

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