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RecruitingLast updated: 18 December 2025

AMT-754-01: This study is recruiting people with advanced solid cancers to evaluate the recommended dose level, safety and effect of a drug called AMT-754First-in-Human, Phase 1 Study of AMT-754, a Targeting Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

AMT-754-01

Clinical summary

Summary

 

This trial is studying 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 tumours. 

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.

All eligible participants will receive AMT-754 which will be administered intravenously (via IV).

The study is recruiting people with advanced solid cancers, with the following tumour types preferred: cervical, head and neck squamous cell carcinoma, oesophageal, endometrial, ovarian, lung and prostate cancer.

Conditions

This trial is treating people with advanced or unresectable solid cancers who have had at least one prior treatment

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Multitude Therapeutics Inc.

Scientific Title

First-in-Human, Phase 1 Study of AMT-754, a Targeting Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

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