GD2-SADA: 177Lu-DOTA

GD2-SADA: 177Lu-DOTA in GD2-Positive Tumors

Agent: GD2-SADA, 177Lu-DOTA
Phase I
Status Recruiting
Sponsor Y-mAbs Therapeutics

 

For further information please also consult https://clinicaltrials.gov/study/NCT05130255

Patients with Sarcoma, Small Cell Lung Cancer, High Risk Neuroblastoma, or Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex.

The treatment uses a two-step approach (pre-targeted radioimmunotherapy).

  1. GD2-SADA – a specially designed antibody-like molecule that binds to tumor cells carrying the protein GD2.
  2. 177Lu-DOTA – a radioactive compound that is administered afterward and attaches to GD2-SADA.

This allows radiation to be delivered directly to tumor cells, while minimizing exposure to healthy tissues.

 

WHO is the trial for?

 The study is intended for patients with advanced or recurrent cancers that express the GD2 protein, such as:

  • Sarcomas (soft tissue or bone sarcomas) (patients ≥ 16 years of age)
  • Other malignancies like Malignant melanoma, Small cell lung cancer, High-risk neuroblastoma (patients ≥ 18 years of age)

Typical eligibility criteria include:

  • Adults or adolescents (depending on cohort)
  • Measurable disease
  • Good performance status (ECOG 0–1)
  • Expected survival of at least 3 months
  • Adequate organ and bone marrow function

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

 This early-phase study aims to determine:

  • Is the treatment safe and tolerable?
  • What is the best dose of the therapy?
  • Are there early signs that the treatment may help shrink tumors?

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.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the US

For further information check here.

Contact :

Name: Joris Wilms
Phone Number: +45 70261414
Email: clinicaltrials@ymabs.com

STUDY DESIGN: What does the study look like?

 This is a Phase 1 open-label study. All participants receive the investigational treatment. There is no placebo group.

The study has three parts:

Part A – GD2-SADA dose escalation: Small groups of patients receive increasing doses to determine the safest dose.

Part B – Radioactive dose escalation: Researchers determine the optimal dose of 177Lu-DOTA.

Part C – Repeated treatment cycles: Patients may receive multiple treatment cycles to evaluate safety and early signs of effectiveness.

In total, approximately 60 patients are expected to participate.

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.org

 

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