Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06597721

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

Led by Adcendo ApS · Updated on 2026-04-17

210

Participants Needed

11

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have pathologically confirmed unresectable advanced solid tumor
  • Patients who have undergone at least one systemic therapy and have progressive disease
  • Patients must have at least one measurable lesion as per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy 23 3 months.
  • Patients must have adequate organ function as indicated by laboratory values
  • Women of childbearing potential must agree to use two effective contraceptive methods during treatment and for 7 months after
  • Male patients must agree to use condoms during treatment and for 4 months after
Not Eligible

You will not qualify if you...

  • Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload
  • Central nervous system (CNS) metastasis
  • Active ocular surface disease or history of cicatricial conjunctivitis or inflammatory conditions predisposing to cicatrizing conjunctivitis, mucus pemphigoid, or penetrating ocular transplants
  • Persistent toxicities from previous systemic anti-neoplastic treatments
  • Known past or current coagulation defects leading to increased bleeding risk
  • Significant cardiac disease including recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, or arrhythmias
  • History of interstitial lung disease or pneumonitis requiring steroids, current or suspected ILD/pneumonitis
  • Prior second malignancy except well-treated basal cell carcinoma or squamous cell carcinoma of the skin
  • Low-risk prostate cancer with Gleason score < 7 and PSA < 10 ng/mL
  • Any cancer or in situ cancer with disease-free period 23 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

Actively Recruiting

2

Yale University Cancer Center

New Haven, Connecticut, United States, 06520

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

5

START San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

6

Macquarie University Hospital

Macquarie Park, New South Wales, Australia, 2109

Actively Recruiting

7

Scientia Clinical Research

Randwick, New South Wales, Australia, 2031

Actively Recruiting

8

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia, 5042

Actively Recruiting

9

Peninsula and South Eastern Haematology and Oncology Group (PSEHOG)

Frankston, Victoria, Australia, 3199

Actively Recruiting

10

Cabrini Hospital

Malvern, Victoria, Australia, 3144

Actively Recruiting

11

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

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Research Team

M

Margaret Mcnaull

CONTACT

S

Sarah Berardini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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