First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
ConditionSolid Tumors (Phase 1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdcendo ApS
About this trial
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed diagnosis of solid tumor
Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
Radiologically or clinically determined progressive disease during or after most recent line of therapy
Measurable disease per RECIST 1.1
Disqualifiers
Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
Prior treatment with an ADC containing a topoisomerase I inhibitor payload
Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
Other malignancy
Trial design
Design model
Single group
Treatments tested in this trial
ADCE-B05
DrugBiological: Antibody-drug conjugate (ADC)
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: ADCE-B05Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the MTD/maximum administered dose of ADCE-B05
Incidence of dose-limiting toxicities (DLTs)
Time frame
From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)2
Assess the safety and tolerability of ADCE-B05
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)
The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment2
Time to maximum concentration (Tmax)
The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment3
Terminal half-life (T[1/2])
The terminal half-life (T\[1/2\]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollment4
Area under the concentration-time curve (AUC)
The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05
Time frame
Throughout the trial duration, completion expected approximately 18 months from completed enrollmentSponsors and contacts
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Source ClinicalTrials.gov