NCT05130255

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2022

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2026

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

November 11, 2021

Results QC Date

March 23, 2026

Last Update Submit

May 21, 2026

Conditions

SCLCMalignant MelanomaSarcomaHigh Risk Neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Cohort 1

EXPERIMENTAL

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)

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Cohort 4

EXPERIMENTAL

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

Cohort 5

EXPERIMENTAL

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

Cohort 6

EXPERIMENTAL

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

Interventions

GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)DRUG

GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV

Also known as: two-step radioimmunotherapy
Cohort 1Cohort 2
GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)DRUG

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

Also known as: two-step radioimmunotherapy
Cohort 4
GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)DRUG

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

Also known as: two-step radioimmunotherapy
Cohort 2
GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi)DRUG

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

Also known as: two-step radioimmunotherapy
Cohort 3
GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)DRUG

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

Also known as: two-step radioimmunotherapy
Cohort 4
GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)DRUG

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

Also known as: two-step radioimmunotherapy
Cohort 3Cohort 5Cohort 6
GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)DRUG

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

Cohort 5Cohort 6

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Corewell Health-BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Memorial Sloan- Kettering Cancer Center

New York, New York, 10065, United States

Location

Case Western Reserve University, Cleveland

Cleveland, Ohio, 44106, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

MelanomaSarcoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft Tissue

Results Point of Contact

Title
Director, Global Statistics
Organization
Y-mAbs Therapeutics
mdu@ymabs.com
+45 5388 5942

Study Officials

  • Taofeek K Owonikoko, MD/PhD

    University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

November 17, 2022

Primary Completion

March 11, 2026

Study Completion

March 11, 2026

Last Updated

June 18, 2026

Results First Posted

June 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(8)