Advanced Solid TumorPhase 1NCT06597721
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
A Phase 1 study testing ADCE-T02 in people with Advanced Solid Tumor and PDAC, run by Adcendo ApS at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, PDAC, HNSCC
- What is being tested?
- ADCE-T02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 25 Nov 2024to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sarah Berardini contact
14 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Yale University Cancer Center
New Haven, Connecticut, 06520
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Highlands Oncology Group
Rogers, Arkansas, 72758
- Recruiting
START San Antonio
San Antonio, Texas, 78229
- Recruiting
Washington University
St Louis, Missouri, 63110
Australia7 sites, 7 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
- Recruiting
Peninsula and South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, 3199
- Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales, 2109
- Recruiting
Cabrini Hospital
Malvern, Victoria, 3144
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
About this study
Official title: First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumor, PDAC, HNSCC
- Being tested
- ADCE-T02
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCE-T02Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| ADCE-T02 Dose Escalation followed by an Expansion Phase | Experimental | Not described Receives: Drug: ADCE-T02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of ADCE-T02
The MTD will be determined using DLTs
Measured: Up to 24 months
Recommended Expansion Phase Dose (RED) of ADCE-T02
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Measured: Up to 24 months
Type, incidence and severity of Adverse Events
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
Measured: Up to 24 months
Secondary outcomes (8)
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Measured: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Measured: Up to 24 months
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Measured: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Measured: Up to 24 months
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of ADCE-T02
Measured: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of ADCE-T02
Measured: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of ADCE-T02
Measured: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Nov 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adcendo ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597721
- Sponsor's protocol ID
- ADCE-T02-001
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Poulsen TT, Ilina O, Wardman JH, Bie A, Bornholdt J, Gillberg M, Pontieri D, Barkholt P, Come C, Zhang Y, Zhang J, Wang Y, Shi H, Liu SH, Meng X, Mumberg D. ADCE-T02 - a Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability. Mol Cancer Ther. 2026 Apr 17. doi: 10.1158/1535-7163.MCT-26-0045. Online ahead of print.
PubMed 41996633
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06597721
- Acronym / sponsor ID
- ADCE-T02-001
- Conditions
- Advanced Solid Tumor, PDAC, HNSCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Adcendo ApSIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADCE-T02 Dose Escalation followed by an Expansion Phase | Experimental | Drug: ADCE-T02 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADCE-T02Administered intravenously | Drug | ADCE-T02 Dose Escalation followed by an Expansion Phase |
Primary outcome
Maximum Tolerated Dose (MTD) of ADCE-T02
Time frame: Up to 24 months
The MTD will be determined using DLTs
Recommended Expansion Phase Dose (RED) of ADCE-T02
Time frame: Up to 24 months
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Type, incidence and severity of Adverse Events
Time frame: Up to 24 months
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
8 secondary outcomes
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Time frame: Up to 24 months
Area under the curve (AUC)
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 41996633Poulsen TT, Ilina O, Wardman JH, Bie A, Bornholdt J, Gillberg M, Pontieri D, Barkholt P, Come C, Zhang Y, Zhang J, Wang Y, Shi H, Liu SH, Meng X, Mumberg D. ADCE-T02 - a Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability. Mol Cancer Ther. 2026 Apr 17. doi: 10.1158/1535-7163.MCT-26-0045. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Berardini contact
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADCE-T02 in people with Advanced Solid Tumor and PDAC, run by Adcendo ApS at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherri Paxton (1(561) 563-3606, Sherri.Paxton@adcendo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of ADCE-T02 (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.