What side effects are associated with this type of intervention?

Common treatments for sarcoma, particularly those involving radioimmunotherapy like the GD2-SADA:177Lu-DOTA trial, often include side effects such as fatigue, nausea, and hematologic toxicities (e.g., low blood counts leading to increased risk of infection, anemia, and bleeding). Additionally, patients may experience localized pain or inflammation at the site of radiation. Long-term side effects can include potential damage to surrounding healthy tissues and organs, leading to issues such as nephrotoxicity or secondary malignancies.

What prior FDA approvals exist?

The FDA has approved several treatments for Sarcoma, though specific approvals for radioimmunotherapy like GD2-SADA:177Lu-DOTA are limited. One notable FDA-approved treatment is olaratumab (Lartruvo), a monoclonal antibody that targets the PDGFR-α receptor, used in combination with doxorubicin for soft tissue sarcoma. Additionally, the FDA has approved peptide receptor radionuclide therapy (PRRT) with Lutetium Lu-177 dotatate for neuroendocrine tumors, which shares similarities with the targeted radiation delivery aspect of the GD2-SADA:177Lu-DOTA trial. However, direct approvals for two-step radioimmunotherapy specifically for Sarcoma are not well-documented.

What other types of research exist?

One promising alternative is the use of Gallium-68-labeled somatostatin analogues (68Ga-DOTA-SSTa) for targeted radionuclide therapy. These agents can assist in therapy selection, prognosis, and tumor response assessment, making them a potential option for sarcoma patients. Additionally, the use of 64Cu or 111In-labeled 2-helix affibody molecules targeting HER2-positive tumors could be explored, as these have shown potential in in vivo targeting and imaging.

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Radioimmunotherapy

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

Phase 1

Recruiting

Led By Taofeek K Owonikoko, MD/PhD

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

Must not have

Prior treatment with anti-GD2 antibody

Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for certain cancers using a two-part method. The first part finds and attaches to cancer cells, and the second part delivers radiation to kill them. It aims to see if this treatment is safe and can be tolerated by patients with Small Cell Lung Cancer, Sarcoma, and 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with anti-GD2 antibody before.

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I haven't had chemotherapy, radiotherapy, immunotherapy, or major surgery in the last 3 weeks.

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I have an autoimmune disease, immunodeficiency, or an active infection with HIV or hepatitis B/C.

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I am experiencing side effects from previous radiation therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for sarcoma include surgery, chemotherapy, and radiotherapy. A novel approach similar to the GD2-SADA:177Lu-DOTA trial involves two-step radioimmunotherapy. In this method, GD2-SADA first targets and binds to cancer cells expressing the GD2 antigen. Subsequently, 177Lu-DOTA is administered, which binds to the GD2-SADA complex and delivers targeted radiation directly to the cancer cells. This targeted approach minimizes damage to surrounding healthy tissues and enhances the efficacy of the treatment. For sarcoma patients, this means potentially more effective treatment with fewer side effects, improving overall outcomes and quality of life.

Evaluation of a New 177Lu-Labeled Somatostatin Analog for the Treatment of Tumors Expressing Somatostatin Receptor Subtypes 2 and 5.Improving Contrast and Detectability: Imaging with [55Co]Co-DOTATATE in Comparison with [64Cu]Cu-DOTATATE and [68Ga]Ga-DOTATATE.Rapid kit-based (68)Ga-labelling and PET imaging with THP-Tyr(3)-octreotate: a preliminary comparison with DOTA-Tyr(3)-octreotate.

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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

Taofeek K Owonikoko, MD/PhDPrincipal InvestigatorUniversity of Maryland, Marlene &amp; Steward Greenebaum Comprehensive Cancer Center 22 S Greene St, Baltimore, MD 21201

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