Investigating ADCE-T02 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Washington University
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Sherri Paxton
• Email: Sherri.Paxton@adcendo.com
• Phone: 1(561) 563-3606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.