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
Qualifiers
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
Treatments tested in this trial
- ADCE-B05
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov