First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

NCT07362888 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ADCE-B05-001
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 7

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)

Outcome Measures

Primary Outcomes (2)

• Determine the MTD/maximum administered dose of ADCE-B05

  Incidence of dose-limiting toxicities (DLTs)

  From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)

• Assess the safety and tolerability of ADCE-B05

  Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Secondary Outcomes (11)

• Maximum concentration (Cmax)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Time to maximum concentration (Tmax)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Terminal half-life (T[1/2])

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Area under the concentration-time curve (AUC)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

• Total antibody (TAb)

  Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Study Arms (1)

ADCE-B05

EXPERIMENTAL

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

Drug: ADCE-B05

Interventions

ADCE-B05 DRUG

Biological: Antibody-drug conjugate (ADC)

ADCE-B05

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adcendo ApS: lead

Study Sites (7)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Health

Clayton, South Australia, 3165, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

Central Study Contacts

Charlotte Lybek Lind

CONTACT

+45 26461897; charlotte.lind@adcendo.com

Margaret McNaull

CONTACT

+44 7818457619; margaret.mcnaull@adcendo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 14, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

AU (4); US (3)