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RecruitingInterventionalPhase 1

First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

NCT ID: NCT06597721Sponsor: Adcendo ApSLast updated: 2026-04-17

Summary

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.

Arms & interventions

  • DrugADCE-T02

    Administered intravenously

Outcome measures

Primary

  • Maximum Tolerated Dose (MTD) of ADCE-T02

    The MTD will be determined using DLTs

    Time frame: Up to 24 months

  • Recommended Expansion Phase Dose (RED) of ADCE-T02

    The RED will be determined using dose limiting toxicities (DLTs) and all other available study data

    Time frame: Up to 24 months

  • Type, incidence and severity of Adverse Events

    Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0

    Time frame: Up to 24 months

Secondary

  • Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 24 months

  • Disease Control Rate (DCR) according to the RECIST v1.1

    Time frame: Up to 24 months

  • Progression-free Survival (PFS)

    Time frame: Up to 24 months

  • Concentration of anti-drug antibodies (ADA)

    Time frame: Up to 24 months

  • Maximum observed concentration (C[max])

    Time frame: Up to 24 months

  • Area under the curve (AUC)

    Time frame: Up to 24 months

  • Terminal half-life (t[1/2])

    Time frame: Up to 24 months

  • Time to maximum concentration (Tmax)

    Time frame: Up to 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: 1. Patients must have pathologically confirmed unresectable advanced solid tumor 2. Patients who have undergone at least one systemic therapy and have progressive disease 3. Patients must have at least one measurable lesion as per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Life expectancy ≥ 3 months. 6. Patients must have adequate organ function as indicated by laboratory values 7. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T02. 8. Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T02. Key Exclusion Criteria: 1. Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload 2. Central nervous system (CNS) metastasis. 3. Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants. 4. Persistent toxicities from previous systemic anti-neoplastic treatments 5. Known past or current coagulation defects leading to an increased risk of bleeding 6. Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias 7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis 8. Prior second malignancy except for: * Well treated basal cell carcinoma or squamous cell carcinoma of the skin. * Low-risk prostate cancer with a Gleason score \< 7 and a PSA level \< 10 ng/mL * Any cancer or in situ cancer the patient has been disease-free for ≥ 2 years.

Study locations (5)

Highlands Oncology Group

Rogers, Arkansas, 72758

Recruiting

Yale University Cancer Center

New Haven, Connecticut, 06520

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

START San Antonio

San Antonio, Texas, 78229

Recruiting

References

  • Poulsen TT, Ilina O, Wardman JH, Bie A, Bornholdt J, Gillberg M, Pontieri D, Barkholt P, Come C, Zhang Y, Zhang J, Wang Y, Shi H, Liu SH, Meng X, Mumberg D. ADCE-T02 - a Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability. Mol Cancer Ther. 2026 Apr 17. doi: 10.1158/1535-7163.MCT-26-0045. Online ahead of print.(PubMed)
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours | Cancerify