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Trial record 1 of 10 for:    SADA
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GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130255
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Y-mAbs Therapeutics

Study Description
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Brief Summary:
Patients with Small Cell Lung Cancer, 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

Condition or disease Intervention/treatment Phase
SCLC Malignant Melanoma Sarcoma Drug: GD2-SADA:177Lu-DOTA Complex Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial With GD2-SADA:177Lu-DOTA Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, Sarcoma and Malignant Melanoma
Actual Study Start Date : November 17, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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

 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
Other Name: two-step radioimmunotherapy


Outcome Measures
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Primary Outcome Measures :
  1. To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations [ Time Frame: 6 weeks ]
    Occurrence of DLTs (Part A)

  2. To determine maximum tolerable activity of 177Lu-DOTA [ Time Frame: 6 weeks ]
    Occurrence of DLTs (Part B)

  3. To assess cumulative toxicity signals and safety profile (Number and severity of adverse events) following repeated dosing and determine the recommended phase 2 dose (RP2D) [ Time Frame: 52 weeks ]
    Number and severity of adverse events (Part C)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130255


Contacts
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Contact: Joris Wilms +4570261414 clinicaltrials@ymabs.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Justin Moser, MD       jmoser@honorhealth.com   
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Janet Yoon, MD       jyoon@coh.org   
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Aditya Juloori, MD       ajuloori1@bsd.uchicago.edu   
United States, Michigan
Corewell Health-BAMF Health Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David Hoogstra, MD       David.Hoogstra@corewellhealth.org   
United States, New York
Memorial Sloan- Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Emily Slotkin, MD       slotkine@mskcc.org   
United States, Ohio
Case Western Reserve University, Cleveland Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Afshin Dowlati, MD       Afshin.Dowlati@UHhospitals.org   
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Taofeek Owonikoko, MD       owonikokotk2@upmc.edu   
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Vincent Ma, MD       vtma@medicine.wisc.edu   
Sponsors and Collaborators
Y-mAbs Therapeutics
Investigators
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Principal Investigator: Taofeek K Owonikoko, MD/PhD UPMC Hillman Cancer Center
More Information
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Responsible Party: Y-mAbs Therapeutics
ClinicalTrials.gov Identifier: NCT05130255    
Other Study ID Numbers: 1001
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue