Back to search results

First-in-Human Study of ADCE-B05 for Advanced Solid Tumors

This study is testing a new drug called ADCE-B05 for people with advanced solid tumors that have progressed despite other treatments. ADCE-B05 is an antibody-drug conjugate (ADC), which means it's designed to deliver a powerful drug directly to cancer cells. The main goals are to find the highest safe dose of ADCE-B05 and to understand its side effects. Researchers will also look at how well it works against the cancer. You might be able to join if you have an advanced solid tumor that has grown or spread, and if standard treatments haven't worked or aren't suitable for you. The study is currently recruiting about 180 participants.

Study design
This is a Phase 1 study, which means it's a first-in-human trial to evaluate a new drug. It plans to enroll 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be assessed throughout the trial, with completion expected about 18 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07362888

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Adcendo ApS
~180 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:ADCE-B05

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the MTD/maximum administered dose of ADCE-B05
Measured over From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
+1 more outcome measured

Conditions

Solid Tumors (Phase 1)

Explore related trials

Solid Neoplasm

NCT07362888

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Highlands Oncology Group

    Springdale, Arkansasno site contact published

    Recruiting

  • Monash Health

    Clayton, Victoria, Australiano site contact published

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, Australiano site contact published

    Recruiting

  • Scientia Clinical Research

    Randwick, New South Wales, Australiano site contact published

    Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, Australiano site contact published

    Recruiting

  • University Of Texas MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • Yale University

    New Haven, Connecticutno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Charlotte Lybek Lind
[email protected]
+45 26461897
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
ECOG performance status of 0 or 1
Adequate hematological and biochemical parameters
A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment

Exclusion

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
Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1
Clinically significant cardiovascular disease
Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
Current active liver disease due to hepatitis B or hepatitis C
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis

What this trial measures

  • Determine the MTD/maximum administered dose of ADCE-B05From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)

    Incidence of dose-limiting toxicities (DLTs)

  • Assess the safety and tolerability of ADCE-B05Throughout the trial duration, completion expected approximately 18 months from completed enrollment

    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