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 — DRUGBiological: 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-B05Dose 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
- Charlotte Lybek Lind+45 26461897
- Margaret McNaull+44 7818457619
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | - |
| Yale University | New Haven | Connecticut | 06520 | - |
| University Of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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