SCLCPhase 1NCT05130255

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

A Phase 1 study testing GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi) and GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi) in people with SCLC and Malignant Melanoma, run by Y-mAbs Therapeutics at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: SCLC, Malignant Melanoma, Sarcoma
What is being tested?: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi) and GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 8 sitesUnited States
Study dates: 17 Nov 2022to 11 Mar 2026
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University, Cleveland
Cleveland, Ohio, 44106
City of Hope National Medical Center
Duarte, California, 91010
Corewell Health-BAMF Health
Grand Rapids, Michigan, 49503
University of Wisconsin-Madison
Madison, Wisconsin, 53705
Memorial Sloan- Kettering Cancer Center
New York, New York, 10065
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15260
HonorHealth
Scottsdale, Arizona, 85258

Other trials in United States

About this study

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

Read the 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.

Conditions: SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
Being tested: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi), GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)
Medical subject headings: Melanoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)Drug
Also called two-step radioimmunotherapy
GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)Drug
Also called two-step radioimmunotherapy
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
Also called two-step radioimmunotherapy
GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA
GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi)Drug
Also called two-step radioimmunotherapy
GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA
GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)Drug
Also called two-step radioimmunotherapy
GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA
GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)Drug
Also called two-step radioimmunotherapy
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)

Study groups in NCT05130255
Study group	Role	What they receive
Cohort 1	Experimental	0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)
Cohort 2	Experimental	0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi); Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
Cohort 3	Experimental	1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)
Cohort 4	Experimental	3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)
Cohort 5	Experimental	1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)
Cohort 6	Experimental	1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA) Receives: Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi); Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicity
Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5
Measured: Within 6 weeks after first IMP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202211 Mar 2026

First posted23 Nov 2021
Study start17 Nov 2022
Primary completion11 Mar 2026
Study completion11 Mar 2026

Why it stopped: Decision by Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SCLCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial
Masking: Single blind
Who is masked: Participant
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05130255
Sponsor's protocol ID: 1001
Status last verified: May 2026
First submitted: 11 Nov 2021
Last updated: 18 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05130255
Acronym / sponsor ID: 1001
Conditions: SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Decision by Sponsor
Enrolment: 23 participants (actual)
Lead sponsor: Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
Study start: 17 Nov 2022 (actual)
Primary completion: 11 Mar 2026 (actual)
Study completion: 11 Mar 2026 (actual)
First posted: 23 Nov 2021 (actual)
Results: Posted 18 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 6
Model description: Phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial

Arm	Type	Receives
Cohort 1	Experimental	Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Cohort 2	Experimental	Drug: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), Drug: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
Cohort 3	Experimental	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi), Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Cohort 4	Experimental	Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), Drug: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Cohort 5	Experimental	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi), Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
Cohort 6	Experimental	Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi), Drug: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi)Also: two-step radioimmunotherapyGD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV	Drug	Cohort 1, Cohort 2
GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi)Also: two-step radioimmunotherapyGD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA	Drug	Cohort 4
GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)Also: two-step radioimmunotherapyGD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA	Drug	Cohort 2
GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi)Also: two-step radioimmunotherapyGD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA	Drug	Cohort 3
GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi)Also: two-step radioimmunotherapyGD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA	Drug	Cohort 4
GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi)Also: two-step radioimmunotherapyGD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA	Drug	Cohort 3, Cohort 5, Cohort 6
GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi)GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)	Drug	Cohort 5, Cohort 6

Primary outcome

Number of Participants With Dose Limiting Toxicity
Time frame: Within 6 weeks after first IMP administration
Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5

Results and safety

Results posted to the registry on 18 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Cohort 1	2	0
Part A Cohort 2	2	1
Part A Cohort 3	5	2
Part A Cohort 4	5	1
Part A Cohort 5	3	0
Part A Cohort 6	6	1

Primary outcome: Number of Participants With Dose Limiting Toxicity

Time frame: Within 6 weeks after first IMP administration. Count of participants. Unit: Participants

Measure	Cohort 1 n = 0	Cohort 2 n = 1	Cohort 3 n = 2	Cohort 4 n = 1	Cohort 5 n = 1	Cohort 6 n = 2
Value	0	0	0	0	0	0

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 2	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 3	1 of 5 (20%)	4 of 5 (80%)	3 of 5
Cohort 4	1 of 5 (20%)	4 of 5 (80%)	0 of 5
Cohort 5	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Cohort 6	1 of 6 (16.7%)	4 of 6 (66.7%)	1 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Taofeek K Owonikoko, MD/PhD principal investigator

University of Maryland, Marlene &amp; Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicity (time frame: Within 6 weeks after first IMP administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.