NCT07362888 First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
| NCT ID | NCT07362888 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adcendo ApS |
| Condition | Solid Tumors (Phase 1) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2026-03-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07362888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors (Phase 1). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07362888 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07362888 currently recruiting?
Yes, NCT07362888 is actively recruiting participants. Contact the research team at charlotte.lind@adcendo.com for enrollment information.
Where is the NCT07362888 trial being conducted?
This trial is being conducted at Springdale, United States, New Haven, United States, Houston, United States, Randwick, Australia and 3 additional locations.
Who is sponsoring the NCT07362888 clinical trial?
NCT07362888 is sponsored by Adcendo ApS. The trial plans to enroll 180 participants.