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

Study Identifier:
ADCE-T02-001
CT.gov Identifier:
NCT06597721
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-754, in Patients with Advanced Solid Tumors To evaluate the safety, pharmacokinetics, and preliminary efficacy of ADCE-T02 as a monotherapy in patients with advanced solid tumors

The expansion cohorts are designed to evaluate two go-forward dose levels in a randomized setting, supporting dose optimization and enabling additional assessments of safety, anti-tumor activity, and durability of response.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: ADCE-T02 Dose Escalation followed by an Expansion Phase
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • 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.
Exclusion criteria
  • 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor