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
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
Study locations (4)
University of Colorado Denver
Aurora, Colorado, 80208
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030