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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

NCT07362888•Adcendo ApS

View on ClinicalTrials.gov

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.

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (7)

Highlands Oncology Group

Springdale, Arkansas, United States

Yale University

New Haven, Connecticut, United States

University Of Texas MD Anderson Cancer Center

Houston, Texas, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Monash Health

Clayton, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

March 31, 2026

Primary Completion Date

December 31, 2026

Completion Date

March 14, 2029

Last Updated

March 3, 2026

Enrollment

180

ESTIMATED participants

Conditions

Solid Tumors (Phase 1)

Interventions

ADCE-B05

DRUG

Contacts

Charlotte Lybek Lind

CONTACT

+45 26461897 charlotte.lind@adcendo.com

Margaret McNaull

CONTACT

+44 7818457619 margaret.mcnaull@adcendo.com

A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

NCT07288957

Solid Tumors (Phase 1)

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A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL