ADCElerate1

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (ADCElerate1)

Agents: ADCE-D01
Phase I/II
Status Recruiting
Sponsor Adcendo ApS

 

For further information please also consult https://www.clinicaltrials.gov/study/NCT06797999

ADCElerate1 is a first-in-human, phase 1/2, open-label, dose escalation and expansion study to evaluate the safety, pharmacokinetics, and antitumor activity of ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma.

ADCE-D01 is a new type of cancer medicine called antibody–drug conjugate (ADC): a humanized anti-human uPARAP antibody, which is linked to a Topoisomerase I Inhibitor.

WHO is the trial for?

  • Adult patients with good overall health status (ECOG 0-1)
  • Histologically confirmed soft tissue sarcoma 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 chemotherapy.Excluded is history of idiopathic pulmonary fibrosis or pneumonitis.

WHAT is the key question that this trial is attempting to answer?

Is ADCE-D01 safe and effective in treating patients with metastatic and/or unresectable soft tissue sarcoma? What is the best tolerable dose?

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

This study is open for recruitment.

WHERE is the trial available?

The trial is currently being conducted in the US, with more study sites to be opened soon in Belgium, France, Germany and United Kingdom. For further information check here.

Contact:

Name: René Smrčka

Phone Number: +45 3144 0653

Email: rene.smrcka@adcendo.com

STUDY DESIGN: What does the study look like?

Phase 1/2 open-label trial: all participants know they’re receiving ADCE‑D01; no placebo group.

Sequential design: First, small groups receive increasing doses (Phase 1).

After determining a safe and active dose, additional participants will be treated to better understand safety and early effectiveness (Phase 2).

HOW do I get more information?

Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

 

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken