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Radioimmunotherapy

GD2-SADA:177Lu-DOTA Complex for Small Cell Lung Cancer

Phase 1

Recruiting

Led By Afshin N Dowlati, MD

Research Sponsored by Y-mAbs Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation

Age ≥18 years at the time of informed consent, for sarcoma age ≥16 years of age at time of informed consent/assent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trialwill assess the safety & tolerance of a two-step treatment for Small Cell Lung Cancer, Sarcoma & Malignant Melanoma.

Who is the study for?

This trial is for adults with Small Cell Lung Cancer, Sarcoma, or Malignant Melanoma. Participants must have a life expectancy over 3 months, certain blood cell counts within range, measurable disease by RECIST 1.1 standards, and good performance status. They should not have had recent cancer treatments or suffer from autoimmune diseases.Check my eligibility

What is being tested?

The trial tests GD2-SADA:177Lu-DOTA Complex on patients to evaluate its safety and how well they tolerate it. It's a two-step radioimmunotherapy involving separate administrations of GD2-SADA and 177Lu-DOTA.See study design

What are the potential side effects?

Potential side effects may include reactions related to radiation exposure such as nausea, fatigue, hair loss; immune system responses like fever or chills; and possible kidney function changes due to the compound's renal processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good based on my creatinine levels.

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I am at least 18 years old, or at least 16 if I have sarcoma.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

To determine maximum tolerable activity of 177Lu-DOTA

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: GD2-SADA:177Lu-DOTA ComplexExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Y-mAbs TherapeuticsLead Sponsor

25 Previous Clinical Trials

1,497 Total Patients Enrolled

2 Trials studying Sarcoma

184 Patients Enrolled for Sarcoma

Afshin N Dowlati, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center (Case Western Reserve University-School of Medicine)

Janet Yoon, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

GD2-SADA:177Lu-DOTA Complex (Radioimmunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05130255 — Phase 1

Sarcoma Research Study Groups: GD2-SADA:177Lu-DOTA Complex

Sarcoma Clinical Trial 2023: GD2-SADA:177Lu-DOTA Complex Highlights & Side Effects. Trial Name: NCT05130255 — Phase 1

GD2-SADA:177Lu-DOTA Complex (Radioimmunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130255 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current geographic scope of this investigation?

"Currently, the medical trial has 6 sites open for enrolment. These include University of Wisconsin-Madison in Madison, Case Western Reserve University and Cleveland, HonorHealth in Scottsdale amongst others."

Answered by AI

What is the magnitude of participation in this research endeavor?

"Affirmative. According to the information published on clinicaltrials.gov, this research endeavour is actively looking for participants and was last updated November 18th 2022. In total, 60 volunteers are expected to be recruited from 6 trial centres across the country."

Answered by AI

What implications does the use of GD2-SADA:177Lu-DOTA Complex have for patient safety?

"Considering the limited clinical data about GD2-SADA:177Lu-DOTA Complex, our team at Power assessed its safety to be a 1. This is because this drug is currently in Phase 1 trials and has yet to undergo extensive safety testing."

Answered by AI

Are new participants currently being enrolled into this research endeavor?

"According to clinicaltrials.gov, this medical trial is actively looking for patients as of November 18th 2022 - the date when the listing was last updated. The initial posting was made on November 17th."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130255.

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