First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Adcendo ApS
Study ID
NCT07362888
Phase
PHASE1
Status
Recruiting

Conditions

  • Solid Tumors (Phase 1)

Eligibility Criteria

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

Interventions

  • ADCE-B05 — DRUG
    Biological: Antibody-drug conjugate (ADC)

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Mar 14, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADCE-B05
    Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle

Primary Outcome Measure

Determine the MTD/maximum administered dose of ADCE-B05 [ Time Frame: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72762-
Yale UniversityNew HavenConnecticut06520-
University Of Texas MD Anderson Cancer CenterHoustonTexas77030-

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