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

Sponsor
Y-mAbs Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05130255
Collaborator
(none)
60
1
28

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 trialPhase 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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 Names:
  • two-step radioimmunotherapy
  • Outcome Measures

    Primary Outcome Measures

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

      Occurrence of DLTs (Part A)

    2. To determine maximum tolerable activity of 177Lu-DOTA [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) [52 weeks]

      Number and severity of adverse events (Part C)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Y-mAbs Therapeutics

    Investigators

    • Principal Investigator: Taofeek K Owonikoko, MD/PhD, UPMC Hillman Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Y-mAbs Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05130255
    Other Study ID Numbers:
    • 1001
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2022