High Risk Neuroblastoma, Malignant Melanoma, Sarcoma, SCLC
Conditions
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.
Interventions
DRUGGD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)
GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
DRUGGD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)
GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA
DRUGGD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA
DRUGGD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi)
GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA
DRUGGD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)
GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA
DRUGGD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)
GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
DRUGGD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)
GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
Sponsors
Y-mAbs Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity | Within 6 weeks after first IMP administration | Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTaofeek K Owonikoko, MD/PhD
University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201
Participant flow
Pre-assignment details
Additional information: The trial contained three parts (Part A, Part B and Part C). Enrollment was completed for Part A of the study only. Part B and Part C were not opened for enrollment. Part A consisted of an Imaging portion and a Therapy portion. Participants with confirmed tumor uptake of 177 Lu in the Imaging portion, moved to the Therapy portion. After enrollment in Part A was completed, the study was terminated by choice of the Sponsor.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 23.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 3 / 5 | 0 / 5 | 0 / 3 | 1 / 6 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 4 / 5 | 4 / 5 | 3 / 3 | 4 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 1 / 5 | 1 / 5 | 1 / 3 | 1 / 6 |
Outcome results
None listed