First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdcendo ApS
About this trial
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
Measurable disease as per RECIST v 1.1.
Disqualifiers
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.
Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
Clinically significant cardiovascular disease
Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
Trial design
Design model
Sequential
Treatments tested in this trial
Antibody-drug conjugate (ADC)
Biological/VaccineADCE-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.
Treatment groups
270 Participants
are divided into 1 treatment groupGroup A: ADCE-D01Other 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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 enrollmentSecondary outcomes
1
Maximum concentration (Cmax)
Time to maximum plasma concentration will be assessed to inform ADCE-D01 PK profile
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment2
ADCE-D01 time to Cmax (Tmax)
Time to Cmax (Tmax) will be assessed to characterize the ADCE-D01 PK profile
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment3
ADCE-D01 area under the concentration-time curve (AUC)
ADCE-D01 area under the concentration-time curve (AUC) will be assessed to characterize PK profile
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment4
Evaluate ADCE-D01 objective response rate (ORR)
Objective response rate (ORR) per RECIST v1.1 by Investigator assessment
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov