First human use of ADCE-B05 for advanced solid tumors
A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors
This trial tests ADCE-B05 to find a safe dose and see if it helps adults with advanced solid tumors that have progressed after approved treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adcendo ApS Industry-sponsored |
| Locations | 7 sites (Springdale, Arkansas and 6 other locations) |
| Trial ID | NCT07362888 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, open-label dose-escalation trial of single-agent ADCE-B05 in adults with unresectable locally advanced or metastatic solid tumors. The main goals are to determine the maximum tolerated dose (MTD), identify a recommended expansion dose, and characterize safety and tolerability by monitoring dose-limiting toxicities. Antitumor activity will be tracked using RECIST v1.1 measures including objective response rate, duration of response, progression-free rate, and time to response. Eligible patients must have measurable disease, ECOG performance status 0–1, and adequate hematologic and biochemical function.
Who should consider this trial
Good fit: Adults with histologically confirmed unresectable locally advanced or metastatic solid tumors that have progressed on or are ineligible for approved therapies, who have measurable disease by RECIST 1.1, ECOG 0–1, and adequate blood and organ function.
Not a fit: Patients with poor performance status (ECOG ≥2), uncontrolled medical conditions, pregnant or breastfeeding women, or those who cannot meet contraception requirements are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ADCE-B05 could provide a new treatment option that controls tumor growth for patients with advanced solid tumors who have exhausted approved therapies.
How similar studies have performed: This is a first-in-human trial, so ADCE-B05 has no prior human efficacy data, although similar early-phase dose-escalation designs are commonly used to establish safety and dosing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria * 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
Where this trial is running
Springdale, Arkansas and 6 other locations
- Highlands Oncology Group — Springdale, Arkansas, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Not_yet_recruiting)
- University Of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Scientia Clinical Research — Randwick, New South Wales, Australia (Recruiting)
- Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (Recruiting)
- Monash Health — Clayton, South Australia, Australia (Not_yet_recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Charlotte Lybek Lind
- Email: charlotte.lind@adcendo.com
- Phone: +45 26461897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.