NCT05130255

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of GD2-SADA:177Lu-DOTA complex in GD2 expressing solid tumors. The trial is planned as a Phase 1 trial with three parts, A, B and C. Escalation in this trial will be based on a classical 3+3 trial design. Part A is a GD2-SADA dose escalation phase, in which patients will receive one treatment cycle. Part B is a 177Lu-DOTA dose escalation phase, in which patients will receive up to 2 treatment cycles . Part C is a repeated dosing phase where the doses determined in Part A and B will be administered. Patients will receive repeated treatment cycles with a maximum of 5 cycles.

Conditions

• SCLC
• Malignant Melanoma
• Sarcoma
• High Risk Neuroblastoma

Interventions

Type	Name	Description
DRUG	GD2-SADA:177Lu-DOTA Complex	The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA, both will be administered as an IV infusion

Timeline

• Start date: 2022-11-17
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2021-11-23
• Last updated: 2024-10-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study