First human use of ADCE-B05 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• Yale University
  New Haven, Connecticut, United States 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, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Charlotte Lybek Lind
• Email: charlotte.lind@adcendo.com
• Phone: +45 26461897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.