NeuroblastomaEarly Phase 1NCT07067346
Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma
A Early Phase 1 study testing IR-101 in people with Neuroblastoma, run by Sichuan University at 2 sites in China.
Trial summary
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- IR-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jul 2025to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
- All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
- Age ≥12 months;
- Lansky performance status ≥50%;
- Adequate organ function and hematologic parameters;
Who cannot join
- Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
- Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration;
- Autologous transplant <12 weeks, or Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD);
- Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or >50% bone marrow) within 12 weeks prior to first dose of study drug;
- Renal Insufficiency;
- Active Infections;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuang
Xiaoai Wu, Phd
- Recruiting
West China Hospital
Chengdu
Xiaoai Wu
About this study
Official title: A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
- Conditions
- Neuroblastoma
- Being tested
- IR-101
- Keywords
- Radiopharmaceutical
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR-101Drug
IR-101 Dose Escalation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Study drug IR-101 Dose Escalation Receives: Drug: IR-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs)
Measured: From administration of IR-101 until 4 weeks after injection
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Measured: From administration of IR-101 until 4 weeks after last dose of injection
Secondary outcomes (2)
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Measured: 4 weeks after IR-101 administration
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Measured: About 21hours from time of IR-101 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start18 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tian, Sichuan University
- Investigators
- Rong Tian, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067346
- Sponsor's protocol ID
- HX2501
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma
- ClinicalTrials.gov ID
- NCT07067346
- Acronym / sponsor ID
- HX2501
- Conditions
- Neuroblastoma
- Keywords
- Radiopharmaceutical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: IR-101Study drug IR-101 Dose Escalation |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
- All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
- Age ≥12 months;
- Lansky performance status ≥50%;
- Adequate organ function and hematologic parameters;
Key exclusion criteria (6 listed)
- Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
- Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration;
- Autologous transplant <12 weeks, or Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD);
- Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or >50% bone marrow) within 12 weeks prior to first dose of study drug;
- Renal Insufficiency;
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 |
|---|---|---|
| IR-101IR-101 Dose Escalation | Drug | Dose Escalation |
Primary outcome
Incidence and severity of dose-limiting toxicities (DLTs)
Time frame: From administration of IR-101 until 4 weeks after injection
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Time frame: From administration of IR-101 until 4 weeks after last dose of injection
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
2 secondary outcomes
Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Time frame: 4 weeks after IR-101 administration
Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Time frame: About 21hours from time of IR-101 administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- 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.
Rong Tian, MD principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IR-101 in people with Neuroblastoma, run by Sichuan University at 2 sites in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tian, MD (18980601586, rongtiannuclear@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose-limiting toxicities (DLTs) (time frame: From administration of IR-101 until 4 weeks after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.