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RecruitingLast updated: 6 August 2026

Testing a new drug called ADCE-B05 in people with advanced solid cancers to find the safest and most effective dose and to understand its side effectsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This study is looking at a drug called ADCE-B05. Researchers are aiming to:
  • find the highest dose that can be given safely (maximum tolerated dose, or MTD)
  • identify the best dose to use in future parts of the study (recommended expansion dose)
  • understand its side effects and how well it is tolerated
Researchers will test different dose levels of ADCE-B05 when it is used alone and will closely monitor participants to learn more about its safety and side effects. ADCE-B05 will be given intravenously in 3 weekly cycles.
 
Who can take part?
You may be eligible for this study if:
  • you have a solid cancer
  • your cancer is advanced, meaning it cannot be removed with surgery (unresectable), is locally advanced, or has spread to other parts of the body (metastatic)
  • your cancer has not responded to approved treatments, you could not tolerate approved treatments, or there are no suitable approved treatments available
  • your cancer has grown or worsened during or after your most recent treatment

Conditions

This trial is treating people with locally advanced, metastatic or unresectable solid cancers

Eligibility

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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Adcendo ApS

Scientific Title

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

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