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

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

Study Overview

• Status: Terminated
• Conditions: Sarcoma; SCLC; Malignant Melanoma; High Risk Neuroblastoma
• Intervention / Treatment: Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi); Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health-BAMF Health
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan- Kettering Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Cleveland
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • UPMC Hillman Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations.
• Age ≥18 years at the time of informed consent, for High Risk Neuroblastoma & sarcoma age ≥16 years of age at time of informed consent/assent
• Measurable disease according to RECIST 1.1
• ECOG performance status 0-1
• Expected survival >3 months
• Platelet counts ≥100,000 cells/mm3
• Hemoglobin ≥9 g/dL
• Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation
• Patient willing and able to comply with the trial protocol

Exclusion Criteria:

• Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
• Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
• Ongoing radiation toxicities from prior RT therapy
• Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
• Prior treatment with anti-GD2 antibody

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi); GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV; Other Names: two-step radioimmunotherapy
Experimental: Cohort 2; 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi); GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV; Other Names: two-step radioimmunotherapy; Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi); GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy
Experimental: Cohort 3; 1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi); GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy; Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy
Experimental: Cohort 4; 3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi); GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy; Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi); GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy
Experimental: Cohort 5; 1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy; Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi); GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
Experimental: Cohort 6; 1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA; Other Names: two-step radioimmunotherapy; Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi); GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose Limiting Toxicity	Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5	Within 6 weeks after first IMP administration

Collaborators and Investigators

• Sponsor: Y-mAbs Therapeutics
• Investigators: Principal Investigator: Taofeek K Owonikoko, MD/PhD, University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): March 11, 2026
• Study Completion (Actual): March 11, 2026

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Neoplasms, Connective and Soft Tissue; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Sarcoma
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No