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

NCT06597721 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ADCE-T02-001
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD) of ADCE-T02

  The MTD will be determined using DLTs

  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

  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

  Up to 24 months

Secondary Outcomes (8)

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

  Up to 24 months

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

  Up to 24 months

• Progression-free Survival (PFS)

  Up to 24 months

• Concentration of anti-drug antibodies (ADA)

  Up to 24 months

• Maximum observed concentration (C[max])

  Up to 24 months

Study Arms (1)

ADCE-T02 Dose Escalation followed by an Expansion Phase

EXPERIMENTAL

Drug: ADCE-T02

Interventions

ADCE-T02 DRUG

Administered intravenously

ADCE-T02 Dose Escalation followed by an Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 3 months.
• Patients must have adequate organ function as indicated by laboratory values
• 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.
• 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.

You may not qualify if:

• 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 a history of cicatricial conjunctivitis or inflammatory conditions that predispose 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 an increased risk of bleeding
• Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis
• 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.

Sponsors & Collaborators

• Adcendo ApS: lead

Study Sites (11)

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

RECRUITING

Yale University Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5042, Australia

RECRUITING

Peninsula and South Eastern Haematology and Oncology Group (PSEHOG)

Frankston, Victoria, 3199, Australia

RECRUITING

Cabrini Hospital

Malvern, Victoria, 3144, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

Central Study Contacts

Margaret Mcnaull

CONTACT

+44 7818457619; margaret.mcnaull@adcendo.com

Sarah Berardini

CONTACT

sarah.berardini@adcendo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-06

Locations

US (5); AU (6)