Metastatic Soft Tissue SarcomaPhase 1/2ADCElerate1NCT06797999
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
A Phase 1/2 study testing Antibody-drug conjugate (ADC) in people with Metastatic Soft Tissue Sarcoma and Unresectable Soft Tissue Sarcoma, run by Adcendo ApS at 9 sites in 5 countries.
Trial summary
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
- What is being tested?
- Antibody-drug conjugate (ADC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 5 Jun 2025to 27 Feb 2029
- Phase
- Phase 1/2
- 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
- ≥ 18 years of age
- Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
- Measurable disease as per RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
- A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.
Who cannot join
- Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
- Clinically significant cardiovascular disease
- Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
- Current active liver disease due to hepatitis B
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
United States4 sites, 4 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80208
Breelyn Wilky, Dr.
- Recruiting
University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Shreyaskumar Patel, Dr.
- Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Jonathan Trent, Dr.
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Robert Maki, Dr.
France2 sites, 2 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69373
Jean-Yves Blay, Prof.
- Not yet recruiting
Institut Gustave Roussy
Paris, Ville Juif Cedex, 94805
Antoine Italiano, Prof.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
Leuven, 3000
Patrick Schöffski, Dr.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Essen West German Tumor Center
Essen, D-45147
Sebastian Bauer, Dr.
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Royal Marsden
London
Robin Jones, Dr.
About this study
Official title: A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Read the detailed description
Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.
- Being tested
- Antibody-drug conjugate (ADC)
- Keywords
- Phase 1/Phase 2, Sequential, Treatment
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody-drug conjugate (ADC)Biological
Also called ADCE-D01
ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.
| Study group | Role | What they receive |
|---|---|---|
| ADCE-D01 | Other | ADCE-D01 Receives: Biological: Antibody-drug conjugate (ADC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
Measuring incidence of dose-limiting toxicities (DLTs)
Measured: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
Assess the safety and tolerability of ADCE-D01
Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0).
Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Secondary outcomes (8)
Maximum concentration (Cmax)
Time to maximum plasma concentration will be assessed to inform ADCE-D01 PK profile
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to Cmax (Tmax)
Time to Cmax (Tmax) will be assessed to characterize the ADCE-D01 PK profile
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 area under the concentration-time curve (AUC)
ADCE-D01 area under the concentration-time curve (AUC) will be assessed to characterize PK profile
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 objective response rate (ORR)
Objective response rate (ORR) per RECIST v1.1 by Investigator assessment
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 duration of response (DOR)
Duration of response DOR, measured per RECIST v1.1 by Investigator assessment will be used to further characterize the durability of tumor response of ADCE-D01
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 progression-free survival (PFS)
Progression-free survival (PFS) assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity.
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollmen
ADCE-D01 clinical benefit rate (CBR)
clinical benefit rate (CBR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to response (TTR)
time to response (TTR) assessed by Investigator per RECIST version 1.1 to evaluate preliminary antitumor activity of ADCE-D01
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start5 Jun 2025
- Primary completion27 Feb 2029 (estimated)
- Study completion27 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Soft Tissue SarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 270 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
- NCT06797999
- Sponsor's protocol ID
- ADCE-D01-001
- Other IDs
- 2024-516900-41-00
- Acronym
- ADCElerate1
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06797999
- Acronym / sponsor ID
- ADCElerate1 / ADCE-D01-001
- Keywords
- Phase 1/Phase 2, Sequential, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Adcendo ApSIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 27 Feb 2029 (estimated)
- Study completion
- 27 Feb 2029 (estimated)
- First posted
- 29 Jan 2025 (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.
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Detailed description
Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADCE-D01 | Other | Biological: Antibody-drug conjugate (ADC)ADCE-D01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
- Measurable disease as per RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (6 listed)
- Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
- Clinically significant cardiovascular disease
- Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
- Current active liver disease due to hepatitis B
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 |
|---|---|---|
| Antibody-drug conjugate (ADC)Also: ADCE-D01ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker. | Biological | ADCE-D01 |
Primary outcome
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
Time frame: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
Measuring incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-D01
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.
8 secondary outcomes
Maximum concentration (Cmax)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to Cmax (Tmax)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 area under the concentration-time curve (AUC)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 objective response rate (ORR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Evaluate ADCE-D01 duration of response (DOR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 progression-free survival (PFS)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollmen
ADCE-D01 clinical benefit rate (CBR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
ADCE-D01 time to response (TTR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
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 11 Sep 2026.
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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.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Antibody-drug conjugate (ADC) in people with Metastatic Soft Tissue Sarcoma and Unresectable Soft Tissue Sarcoma, run by Adcendo ApS at 9 sites in 5 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 6 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 11 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 9 sites in United States, France, Belgium, Germany, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 René Smrčka (+45 3144 0653, rene.smrcka@adcendo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01. (time frame: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.