CLR 131 for Pediatric Cancer

(CLOVER-2 Trial)

Not currently recruiting at 7 trial locations

Overseen By Kate Oliver

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Cellectar Biosciences, Inc.

Must not be taking: Antitumor, Investigational

Disqualifiers: CNS metastases, I-131 dose > 54 mCi/kg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 85 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of CLR 131, an experimental treatment for young people with certain cancers that have returned or resisted treatment, specifically solid tumors, lymphoma, and brain tumors. Administered through an IV, the trial aims to determine if CLR 131 can help treat these challenging cancers. Children, teens, and young adults with these specific cancers, for whom other treatments have failed, might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received antitumor or investigational therapy within 2 weeks of dosing, and certain types of radiation require a 3-month gap. Please discuss your specific medications with the trial team.

Is there any evidence suggesting that CLR 131 is likely to be safe for humans?

Research has shown that CLR 131 has been tested for safety in other patients. In earlier studies with adults who had head and neck cancer, CLR 131 was safe when combined with EBRT, a type of radiation therapy. Most participants tolerated it well, though some experienced serious blood-related side effects.

This study is in its early stages, so researchers are still carefully assessing the treatment's safety in children and young adults. While CLR 131 appears promising, risks remain. It is crucial to consult a doctor to determine if joining the trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CLR 131 is unique because it delivers a radioactive iodine compound directly to cancer cells, which could potentially minimize damage to healthy tissues. Unlike traditional treatments for pediatric cancer, such as chemotherapy and radiation, which can affect both cancerous and healthy cells, CLR 131 uses a targeted approach. Researchers are excited about this treatment because it offers a novel mechanism that directly attacks cancer cells, potentially reducing side effects and improving outcomes for young patients.

What evidence suggests that CLR 131 might be an effective treatment for pediatric cancer?

Research has shown that CLR 131, the treatment under study in this trial, may help treat certain cancers. In studies, CLR 131 found and shrank tumors in both children and adults. Specifically, early results from a small group of children with relapsed high-grade gliomas, a type of brain cancer, suggested it might help them live longer. This treatment delivers targeted radiation directly to cancer cells, potentially protecting healthy tissue. Although more research is needed, these early findings offer hope for those with cancers that have limited treatment options. ^{1 3 6 7 8}

Who Is on the Research Team?

Jarrod Longcor

Principal Investigator

Cellectar Biosciences

Are You a Good Fit for This Trial?

This trial is for young people aged 2-25 with certain types of cancer (like neuroblastoma, sarcomas) that have come back or didn't respond to treatment. They should be fairly active (able to care for themselves), have decent blood counts and organ function, and not be on other cancer treatments. Those who've had a bone marrow transplant must wait at least 3 months before joining.

Inclusion Criteria

I had a bone marrow transplant within the required time frame.

Patients must meet specific blood count criteria

Patient or legal representative must be compliant with the protocol

Exclusion Criteria

My brain involvement from cancer is stable after treatment.

I have been treated with high doses of iodine-131 for my condition.

I have not recently received any cancer treatment or been part of a drug trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CLR 131 intravenous administration with dose escalation to determine the recommended phase 2 dose

up to 85 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of overall survival and event-free survival

1 month to 5 years

Dosimetry Assessment

Assessment of dosimetry via whole body planar imaging

up to 15 days post initial infusion

What Are the Treatments Tested in This Trial?

Interventions

• CLR 131

Trial Overview The study tests CLR 131 in children and young adults with relapsed or stubborn cancers including brain tumors, lymphomas, and solid tumors like osteosarcoma. It aims to find out if this drug can help when other treatments haven't worked.

How Is the Trial Designed?

Group I: CLR 131 Experimental Treatment 1 Intervention

CLR 131 intravenous administration

CLR 131 is already approved in United States, European Union for the following indications:

Approved in United States as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma
• Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia
• Diffuse large B-cell lymphoma

Approved in European Union as Iopofosine I-131 for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Cellectar Biosciences, Inc.

Lead Sponsor

Trials

15

Recruited

1,300+

Citations

1. cellectar.com cellectar.com/news-media/press-releases/detail/379/cellectar-biosciences-receives-rare-pediatric-disease

Press Releases “Receiving Rare Pediatric Disease Designation for iopofosine I 131 underscores its potential to address one of the most devastating cancers ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03478462

NCT03478462 | Dose Escalation Study of CLR 131 in ... Therapeutic efficacy has been demonstrated in various pediatric and adult-type cancer xenograft models, confirming the ability of CLR 131 to target tumors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6785791/

Preclinical Pharmacokinetics and Dosimetry Studies ... CLR1404 is a suitable theranostic scaffold for dosimetry and therapy with potentially broad applicability in pediatric oncology.

4. cancernetwork.com cancernetwork.com/view/iopofosine-i-131-shows-preliminary-survival-benefit-in-pediatric-r-r-glioma

Iopofosine I 131 Shows Preliminary Survival Benefit in ... Treatment with iopofosine I 131 demonstrated early survival benefit in a small cohort of pediatric patients with relapsed/refractory high-grade gliomas.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02952508

NCT02952508 | Study of Iopofosine I 131 (CLR ... This study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL) ...

6. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00532-2/fulltext

Safety and toxicity of Iopofosine I 131 (CLR ... CLR 131 in combination with EBRT did not confer any safety concerns, and was tolerable in participants with recurrent/metastatic HNC. Myelosuppression was ...

7. redjournal.org redjournal.org/article/S0360-3016(24)00128-7/abstract

Safety and Toxicity of Iopofosine I-131 with External Beam ... CLR 131 at a fractionated dose of 15.6 mCi/m2 in combination with EBRT was safe and tolerable in pts with recurrent/metastatic HNC.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39671752/

Safety and toxicity of Iopofosine I 131 (CLR 131) with external ... Findings: Twelve participants completed treatment with CLR 131 and EBRT. Eight participants experienced grade 4 non-DLT haematologic toxicities ...