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

NCT05130255 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

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

Conditions

SCLC; Malignant Melanoma; Sarcoma; High Risk Neuroblastoma

Outcome Measures

Primary Outcomes (3)

• To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations

  Occurrence of DLTs (Part A)

  6 weeks

• To determine maximum tolerable activity of 177Lu-DOTA

  Occurrence of DLTs (Part B)

  6 weeks

• 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)

  Number and severity of adverse events (Part C)

  52 weeks

Study Arms (1)

GD2-SADA:177Lu-DOTA Complex

EXPERIMENTAL

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

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

Also known as: two-step radioimmunotherapy

GD2-SADA:177Lu-DOTA Complex

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Y-mAbs Therapeutics: lead

Study Sites (8)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Corewell Health-BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Memorial Sloan- Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Case Western Reserve University, Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15260, United States

ACTIVE NOT RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Sarcoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue

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

Central Study Contacts

Joris Wilms

CONTACT

+45 70261414; clinicaltrials@ymabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: November 17, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (8)