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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: ADCE-T02

• Registration Number: NCT06597721
• Lead Sponsor: Adcendo ApS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Study Start: 2024-11-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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
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 history of malignancy other than inclusion diagnosis within five years prior to first dose of ADCE T02.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADCE-T02 Dose Escalation	ADCE-T02	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of ADCE-T02	Up to 24 months	The MTD will be determined using DLTs
Recommended Phase 2 Dose (RP2D) of ADCE-T02	Up to 24 months	The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Type, incidence and severity of Adverse Events	Up to 24 months	Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0

Secondary Outcome Measures

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

Trial Locations

Locations (6)

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

Peninsula and South Eastern Haematology and Oncology Group (PSEHOG); 🇦🇺 Frankston, Victoria, Australia

Cabrini Hospital; 🇦🇺 Malvern, Victoria, Australia

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia