What this study is
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.
The expansion phase is now open for enrollment in indications including HNSCC and PDAC.
What's being tested
- ADCE-T02
Intervention · DRUG
Administered intravenously
Study details
- Official title
- First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
- Sponsor
- Adcendo ApS
- Conditions
- Advanced Solid Tumor · PDAC · HNSCC
- Enrolling
- 210 people
- Starts
- 2024-11-25
- Est. completion
- 2027-06-30
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openHighlands Oncology Group
Rogers, Arkansas, United States
RecruitingYale University Cancer Center
New Haven, Connecticut, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
RecruitingWashington University
St Louis, Missouri, United States
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
RecruitingSTART San Antonio
San Antonio, Texas, United States
Recruiting
7 sites outside the US
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
RecruitingScientia Clinical Research
Randwick, New South Wales, Australia
RecruitingSouthern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
RecruitingPeninsula and South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, Australia
RecruitingCabrini Hospital
Malvern, Victoria, Australia
RecruitingPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RecruitingLinear Clinical Research
Nedlands, Western Australia, Australia
Recruiting
Study team
Sponsor
Adcendo ApS
Study ID ADCE-T02-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.