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Decision by Sponsor
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
|
| Cohort 2 | Experimental | 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA) |
|
| Cohort 3 | Experimental | 1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
|
| Cohort 4 | Experimental | 3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
|
| Cohort 5 | Experimental | 1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi) | Drug | GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity | Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5 | Within 6 weeks after first IMP administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taofeek K Owonikoko, MD/PhD | University of Maryland, Marlene & Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| City of Hope National Medical Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Cohort 1 | 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| FG001 | Part A Cohort 2 | 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2024 |
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Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
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| Cohort 6 | Experimental | 1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA) |
|
| GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi) | Drug | GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA |
|
|
| GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi) | Drug | GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA |
|
|
| GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi) | Drug | GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA |
|
|
| GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi) | Drug | GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA |
|
|
| GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi) | Drug | GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA |
|
|
| GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi) | Drug | GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi) |
|
| Duarte |
| California |
| 91010 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Corewell Health-BAMF Health | Grand Rapids | Michigan | 49503 | United States |
| Memorial Sloan- Kettering Cancer Center | New York | New York | 10065 | United States |
| Case Western Reserve University, Cleveland | Cleveland | Ohio | 44106 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15260 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
| FG002 | Part A Cohort 3 | 1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| FG003 | Part A Cohort 4 | 3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| FG004 | Part A Cohort 5 | 1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA) |
| FG005 | Part A Cohort 6 | 1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Cohort 1 | 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| BG001 | Part A Cohort 2 | 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA) |
| BG002 | Part A Cohort 3 | 1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| BG003 | Part A Cohort 4 | 3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) |
| BG004 | Part A Cohort 5 | 1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA) |
| BG005 | Part A Cohort 6 | 1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity | Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5 | Patients evaluable for DLTs who either received the GD2-SADA dose and the 177Lu-DOTA dose in the imaging portion and in the therapy portion and who as a minimum was evaluated during the 6 weeks DLT evaluation period, or who had a DLT during the DLT evaluation period. No DLTs were observed in patients evaluable for DLTs. Only a minority of patients were evaluable for DLTs. | Posted | Count of Participants | Participants | Within 6 weeks after first IMP administration |
|
|
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All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-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 Therapy: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (200 mCi): GD2-SADA IV at 0.3 mg/kg followed by 200 mCi 177Lu-DOTA IV | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Cohort 2 | 0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-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 Therapy: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Cohort 3 | 1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA | 3 | 5 | 1 | 5 | 4 | 5 |
| EG003 | Cohort 4 | 3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA Therapy: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA | 0 | 5 | 1 | 5 | 4 | 5 |
| EG004 | Cohort 5 | 1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi) | 0 | 3 | 1 | 3 | 3 | 3 |
| EG005 | Cohort 6 | 1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA) Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi) | 1 | 6 | 1 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Chills | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
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| Thirst | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Device malfunction | Product issues | MedDRA (28.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Global Statistics | Y-mAbs Therapeutics | +45 5388 5942 | mdu@ymabs.com |
| Mar 20, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|