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

Primary Purpose

SCLC, Malignant Melanoma, Sarcoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GD2-SADA:177Lu-DOTA Complex

About this trial

This is an interventional treatment trial for SCLC

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GD2-SADA:177Lu-DOTA Complex

Arm Description

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

Outcomes

Primary Outcome Measures

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

Occurrence of DLTs (Part A)

To determine maximum tolerable activity of 177Lu-DOTA

Occurrence of DLTs (Part B)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05130255

First Posted

November 11, 2021

Last Updated

August 1, 2023

Sponsor

Y-mAbs Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05130255

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Y-mAbs Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SCLC, Malignant Melanoma, Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GD2-SADA:177Lu-DOTA Complex

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

GD2-SADA:177Lu-DOTA Complex

Other Intervention Name(s)

two-step radioimmunotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Occurrence of DLTs (Part A)

Time Frame

6 weeks

Title

To determine maximum tolerable activity of 177Lu-DOTA

Description

Occurrence of DLTs (Part B)

Time Frame

6 weeks

Title

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)

Description

Number and severity of adverse events (Part C)

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joris Wilms

Phone

+4570261414

clinicaltrials@ymabs.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taofeek K Owonikoko, MD/PhD

Organizational Affiliation

UPMC Hillman Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

HonorHealth

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Justin Moser, MD

jmoser@honorhealth.com

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janet Yoon, MD

jyoon@coh.org

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aditya Juloori, MD

ajuloori1@bsd.uchicago.edu

Facility Name

Corewell Health-BAMF Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Hoogstra, MD

David.Hoogstra@corewellhealth.org

Facility Name

Memorial Sloan- Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily Slotkin, MD

slotkine@mskcc.org

Facility Name

Case Western Reserve University, Cleveland

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Afshin Dowlati, MD

Afshin.Dowlati@UHhospitals.org

Facility Name

UPMC Hillman Cancer Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15260

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taofeek Owonikoko, MD

owonikokotk2@upmc.edu

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent Ma, MD

vtma@medicine.wisc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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

SCLC, Malignant Melanoma, Sarcoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial