Recruiting
Phase 1

ADCE-B05

Sponsor:

Adcendo ApS

Code:

NCT07362888

Conditions

Solid Tumors (Phase 1)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADCE-B05

Study Details

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.

Conditions

Solid Tumors (Phase 1)

Study ID

NCT07362888

Start date

Mar 17, 2026

Status verified date

Jul, 2026

Completion date

Mar 14, 2029

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADCE-B05

Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle

Interventions

ADCE-B05

Biological: Antibody-drug conjugate (ADC)

Primary outcome measure

  • Determine the MTD/maximum administered dose of ADCE-B05 [ Time Frame: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment) ]
  • Assess the safety and tolerability of ADCE-B05 [ Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment ]

Central Contacts and Locations

Central contacts

Charlotte Lybek Lind

+45 26461897charlotte.lind@adcendo.com

Margaret McNaull

+44 7818457619margaret.mcnaull@adcendo.com

Locations

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

University Of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Adcendo ApS

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Adcendo ApS on 2026-07-24.