NCT05130255

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

Recruiting now Phase 1 Last updated 30 September 2024

What this trial tests

Phase 1 trial testing GD2-SADA:177Lu-DOTA Complex in SCLC in 60 participants. Currently enrolling.

Timeline

17 November 2022

Primary endpoint
1 March 2027

1 April 2027

Quick facts

Lead sponsor	Y-mAbs Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	17 November 2022
Primary completion	1 March 2027
Estimated completion	1 April 2027
Sites	8 locations across United States

Drugs / interventions tested

• GD2-SADA:177Lu-DOTA Complex — full drug profile →

Conditions studied

• SCLC — all drugs for SCLC →
• Malignant Melanoma — all drugs for Malignant Melanoma →
• Sarcoma — all drugs for Sarcoma →
• High Risk Neuroblastoma — all drugs for High Risk Neuroblastoma →

Sponsor

Y-mAbs Therapeutics — full company profile →

Who can join

16 and older, any sex, with SCLC or Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations
  Time frame: 6 weeks
  Occurrence of DLTs (Part A)
• To determine maximum tolerable activity of 177Lu-DOTA
  Time frame: 6 weeks
  Occurrence of DLTs (Part B)
• To assess cumulative toxicity signals and safety profile (Number and severity of adverse events) following repeated dosing and determine the recommended phase 2 dose (RP2D)
  Time frame: 52 weeks
  Number and severity of adverse events (Part C)

Sponsor's own description

Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
2. Pretargeting: A Path Forward for Radioimmunotherapy.
   Cheal SM, Chung SK, Vaughn BA, Cheung NV, et al · · 2022 · cited 54× · PMID 36215514 · DOI 10.2967/jnumed.121.262186
3. Promise and Challenges of T Cell Immunotherapy for Osteosarcoma.
   Park JA, Cheung NV. · · 2023 · cited 26× · PMID 37569894 · DOI 10.3390/ijms241512520
4. Current clinical application of lutetium‑177 in solid tumors (Review).
   Niu T, Fan M, Lin B, Gao F, et al · · 2024 · cited 13× · PMID 38596660 · DOI 10.3892/etm.2024.12514
5. Global Impact of Monoclonal Antibodies (mAbs) in Children: A Focus on Anti-GD2.
   Larrosa C, Mora J, Mora J, Cheung NK. · · 2023 · cited 13× · PMID 37509390 · DOI 10.3390/cancers15143729
6. Engineered Antibodies as Cancer Radiotheranostics.
   Wei Z, Li B, Wen X, Jakobsson V, et al · · 2024 · cited 11× · PMID 38874523 · DOI 10.1002/advs.202402361
7. New Approaches in Radiotherapy.
   Webster M, Podgorsak A, Li F, Zhou Y, et al · · 2025 · cited 9× · PMID 40563630 · DOI 10.3390/cancers17121980
8. Radioimmunotheragnosis in Cancer Research.
   Garaulet G, Báez BB, Medrano G, Rivas-Sánchez M, et al · · 2024 · cited 5× · PMID 39199666 · DOI 10.3390/cancers16162896