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

NCT05130255 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-06-18

Study results available
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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

Conditions

  • SCLC
  • Malignant Melanoma
  • Sarcoma
  • High Risk Neuroblastoma

Interventions

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

DRUG

GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)

GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA

DRUG

GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)

GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA

DRUG

GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi)

GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA

DRUG

GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)

GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA

DRUG

GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)

GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA

DRUG

GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)

GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    lead INDUSTRY

Principal Investigators

  • Taofeek K Owonikoko, MD/PhD · University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2026-03-11
Completion
2026-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130255 on ClinicalTrials.gov