Clinical trial NCT05130255: GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Official title: Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: SCLC
Malignant Melanoma
Sarcoma
High Risk Neuroblastoma
Lead sponsor: Y-mAbs Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
Primary purpose: TREATMENT

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

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.

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 High Risk Neuroblastoma \&amp; 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 \&gt;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

Primary outcomes:
measure: To determine the optimal, safe GD2-SADA protein dose and dosing interval between GD2-SADA and 177Lu-DOTA administrations
timeFrame: 6 weeks
measure: To determine maximum tolerable activity of 177Lu-DOTA
timeFrame: 6 weeks
measure: 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)
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Grand Rapids
country: United States
facility: Corewell Health-BAMF Health
state: Michigan
city: New York
country: United States
facility: Memorial Sloan- Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University, Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Maryland, Marlene &amp;amp; Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201
name: Taofeek K Owonikoko, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: