ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

September 3, 2026 updated by: Adcendo ApS

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

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.

The expansion phase is now open for enrollment in indications including HNSCC and PDAC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University Hospital
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Scientia Clinical Research
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Southern Oncology Clinical Research Unit
        • Principal Investigator:
          • Ganessan Kichenadasse
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula and South Eastern Haematology and Oncology Group (PSEHOG)
        • Principal Investigator:
          • Vinod Ganju
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Hospital
        • Principal Investigator:
          • Prachi Bhave
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
        • Principal Investigator:
          • Rajiv Shinde
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADCE-T02 Dose Escalation followed by an Expansion Phase
Drug: ADCE-T02
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of ADCE-T02
Time Frame: Up to 24 months
The MTD will be determined using DLTs
Up to 24 months
Type, incidence and severity of Adverse Events
Time Frame: Up to 24 months
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
Up to 24 months
Recommended Expansion Phase Dose (RED) of ADCE-T02
Time Frame: Up to 24 months
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR) according to the RECIST v1.1
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or Stable Disease (SD)
Up to 24 months
Progression-free Survival (PFS)
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time Frame: Up to 24 months
Immunogenicity profile characterized by concentration of ADAs
Up to 24 months
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 24 months
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Up to 24 months
Time to maximum concentration (Tmax)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax)
Up to 24 months
Maximum observed concentration (C[max])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of ADCE-T02
Up to 24 months
Area under the curve (AUC)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the area under the curve (AUC) of ADCE-T02
Up to 24 months
Terminal half-life (t[1/2])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of ADCE-T02
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adcendo ApS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADCE-T02-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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