Investigating ADCE-T02 for advanced solid tumors

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

This study is testing a new drug called ADCE-T02 to see if it can safely help people with advanced solid tumors that can't be surgically removed.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adcendo ApS (industry)
• Locations: 11 sites (Rogers, Arkansas and 10 other locations)
• Trial ID: NCT06597721 on ClinicalTrials.gov

What this trial studies

This phase 1 study evaluates ADCE-T02, a tissue factor targeted antibody-drug conjugate, in patients with unresectable advanced solid tumors. The primary aim is to determine the Maximum Tolerated Dose (MTD) and assess the safety and tolerability of the drug when administered as a single therapy across various dose levels. Participants must have experienced disease progression after at least one systemic therapy and have measurable lesions. The study is being conducted at multiple locations, including MD Anderson Cancer Center.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable advanced solid tumors who have progressed after prior systemic therapy.

Not a fit: Patients with resectable tumors or those who have not undergone any prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Rogers, Arkansas and 10 other locations

• Highlands Oncology Group — Rogers, Arkansas, United States (RECRUITING)
• Yale University Cancer Center — New Haven, Connecticut, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• START San Antonio — San Antonio, Texas, United States (RECRUITING)
• Macquarie University Hospital — Macquarie Park, New South Wales, Australia (RECRUITING)
• Scientia Clinical Research — Randwick, New South Wales, Australia (RECRUITING)
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (RECRUITING)
• Peninsula and South Eastern Haematology and Oncology Group (PSEHOG) — Frankston, Victoria, Australia (RECRUITING)
• Cabrini Hospital — Malvern, Victoria, Australia (RECRUITING)
• Linear Clinical Research — Nedlands, Western Australia, Australia (RECRUITING)

Study contacts

• Study coordinator: Margaret Mcnaull

Conditions: Advanced Solid Tumor