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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors (Phase 1)
• Intervention / Treatment: Drug: ADCE-B05

Detailed Description

Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Margaret McNaull; Phone Number: +44 7818457619; Email: margaret.mcnaull@adcendo.com
• Study Contact Backup: Name: Charlotte Lybek Lind; Phone Number: +45 26461897; Email: charlotte.lind@adcendo.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Southern Oncology Clinical Research Unit
    • Clayton, South Australia, Australia, 3165
      • Not yet recruiting
      • Monash Health
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Not yet recruiting
      • Peter MacCallum Cancer Centre
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Highlands Oncology Group
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADCE-B05; Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle	Drug: ADCE-B05; Biological: Antibody-drug conjugate (ADC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax)	The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to maximum concentration (Tmax)	The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Terminal half-life (T[1/2])	The terminal half-life (T[1/2]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Area under the concentration-time curve (AUC)	The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Total antibody (TAb)	The total antibody will be assessed to characterize the Pharmacokinetic profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Free (de-conjugated) payload	The free (de-conjugated) payload will be assessed to characterize PK profile of ADCE-B05	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR)	Objective response rate (ORR) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response (DOR)	Duration of response DOR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Progression-free survival (PFS)	Progression-free survival (PFS) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Disease Control Rate (DCR)	DCR will be assessed by investigator per RECIST v1.1 to evaluate preliminary antitumor activity	Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to Response (TTR)	TTR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity	Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Collaborators and Investigators

• Sponsor: Adcendo ApS

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 14, 2029

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ADCE-B05-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No