Actively Recruiting
First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
Led by Adcendo ApS · Updated on 2026-04-15
180
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of solid tumor
- Advanced disease that is unresectable locally advanced or metastatic
- Disease progression during or after most recent therapy
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate blood and biochemical test results
- Male patients must agree to use barrier contraception during treatment and for at least 4 months after last infusion and avoid sperm donation during this period
- Male patients with pregnant partners must use barrier contraception or practice sexual abstinence to protect fetus or newborn
- Female patients must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for at least 7 months after last infusion
You will not qualify if you...
- Treatment with systemic anticancer therapy or investigational agent within 3 weeks or 5 half-lives prior to study treatment
- Prior treatment with an ADC containing topoisomerase I inhibitor payload
- Primary brain cancer or untreated CNS or leptomeningeal metastases, or symptoms requiring CNS treatment
- Other malignancies
- Major surgery or significant injury within 28 days before study drug
- Active systemic infection requiring treatment besides prophylaxis
- Persistent side effects from previous anti-cancer treatments greater than Grade 1
- Clinically significant heart disease
- Active HIV-1 or HIV-2 infection
- Active hepatitis B or C liver disease
- History or evidence of lung diseases such as idiopathic pulmonary fibrosis, drug-induced pneumonitis, or pulmonary lymphangitic carcinomatosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Not Yet Recruiting
3
University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
5
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
6
Monash Health
Clayton, South Australia, Australia, 3165
Not Yet Recruiting
7
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Not Yet Recruiting
Research Team
C
Charlotte Lybek Lind
CONTACT
M
Margaret McNaull
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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