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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Y-mAbs Therapeutics
Study ID
NCT05130255
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GD2-SADA:177Lu-DOTA Complex — DRUG
    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

Study Details

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

Key Dates

Start date
Nov 17, 2022
Status verified
Sep 2024
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GD2-SADA:177Lu-DOTA Complex
    GD2-SADA IV. infusion followed by 177Lu-DOTA IV. infusion (The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA ). 1 treatment cycle in Part A, 2 treatment cycles in Part B and up to 5 treatment cycles in Part C

Primary Outcome Measure

To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations [ Time Frame: 6 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258
Justin Moser, MD
[email protected]
City of Hope National Medical CenterDuarteCalifornia91010
Janet Yoon, MD
[email protected]
University of ChicagoChicagoIllinois60637
Aditya Juloori, MD
[email protected]
Corewell Health-BAMF HealthGrand RapidsMichigan49503
David Hoogstra, MD
[email protected]
Memorial Sloan- Kettering Cancer CenterNew YorkNew York10065
Emily Slotkin, MD
[email protected]
Case Western Reserve University, ClevelandClevelandOhio44106
Afshin Dowlati, MD
[email protected]
UPMC Hillman Cancer CenterPittsburghPennsylvania15260-
University of Wisconsin-MadisonMadisonWisconsin53705
Vincent Ma, MD
[email protected]

Find similar trials in Scottsdale, AZ

By condition
MelanomaLung cancer
By specialty
OncologySkin cancerDermatologyLung oncologyLung disease
By research site
HonorHealth· Scottsdale, AZCity of Hope National Medical Center· Duarte, CAUniversity of Chicago· Chicago, ILCorewell Health-BAMF Health· Grand Rapids, MIMemorial Sloan- Kettering Cancer Center· New York, NYCase Western Reserve University, Cleveland· Cleveland, OH

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