Solid TumorPhase 1NCT07911293
Intratumoral Chlorine Dioxide Injection in Advanced Solid Tumors
A Phase 1 study testing Chlorine Dioxide Injection 2% in people with Solid Tumor and Neoplasms, run by SunGlow Innovations LLC.
Trial summary
The purpose of this study is to evaluate the safety of injecting a 2% chlorine dioxide solution directly into tumors in adults with advanced solid tumors, and to determine whether the injected solution stays within the tumor under real-time imaging guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Neoplasms
- What is being tested?
- Chlorine Dioxide Injection 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Mar 2029
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years.
- Histologically confirmed extracranial solid tumor (primary, locally recurrent or metastatic) that is advanced or unresectable (technically unresectable, medically inoperable, without a remaining standard curative surgical option, or with curative treatment at disproportionate cost such as loss of an entire organ or major function, as documented by a multidisciplinary team), or that has active disease after standard therapy and for which standard local treatment is assessed as unsuitable.
- At least 1 and no more than 10 target lesions at entry. A target lesion is a non-intracranial lesion, visible on imaging, that can be safely reached by ultrasound- or CT-guided percutaneous puncture or injected under direct vision. Not every visible lesion has to be injectable. Non-target lesions may be present and are recorded. Where safe and feasible, all safely reachable visible lesions are listed as target lesions.
- Contrast-enhanced CT (with ultrasound or MRI where needed) completed before entry, establishing the inventory of all visible lesions and of target lesions with their volumes. PET-CT is encouraged but not required.
- Every target lesion <= 10 cm in greatest dimension.
- ECOG performance status <= 2; life expectancy >= 3 months.
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- Platelet count >= 50 x 10^9/L and INR <= 1.5. Anticoagulant and antiplatelet therapy is withheld or bridged as for image-guided percutaneous puncture.
- Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m².
- Able to understand the study and give written informed consent.
- Subjects of reproductive potential, and male subjects with partners of reproductive potential, agree to use effective contraception from consent until 3 months after the last session.
Who cannot join
- No lesion that can be safely punctured or injected under direct vision, or the lesion(s) to be treated encase major vessels or nerves such that the risk of access is unacceptable.
- Severe coagulopathy or high bleeding risk.
- Uncontrolled serious infection, systemic decompensation, severe cachexia or multi-organ failure.
- Pregnancy or lactation.
- Psychiatric or cognitive impairment preventing cooperation.
- Intracranial tumor or intracranial metastasis.
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- Rapidly progressive, widespread disease for which local treatment of target lesions is assessed by the MDT as having no clinical value.
- Contraindication to the procedures or medications required by this protocol without an alternative (e.g., inability to tolerate puncture under local anesthesia with intravenous analgesia).
- Candidate for curative treatment that can be delivered with low morbidity.
- Hypersensitivity to iodinated contrast or uncontrolled hyperthyroidism, where a lesion requires CT guidance. Such a lesion may be treated under ultrasound guidance only.
- Any other condition rendering the subject unsuitable in the investigator's judgment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label, Single-Arm Study of the Safety, Containment and Local Activity of Intratumoral Chlorine Dioxide Injection 2% in Patients With Advanced Extracranial Solid Tumors Accessible to Image-Guided Percutaneous or Direct Injection
The purpose of this study is to evaluate the safety of injecting a 2% chlorine dioxide solution directly into tumors in adults with advanced solid tumors, and to determine whether the injected solution stays within the tumor under real-time imaging guidance. Chlorine dioxide reacts with and destroys the tissue it contacts and is consumed locally within about a minute. Up to about 50 participants will receive up to 4 treatment sessions per lesion, about one week apart, and will be followed for 12 months.
Read the detailed description
Chlorine Dioxide Injection 2% is a ready-to-use solution of chlorine dioxide in 0.9% sodium chloride, injected into the tumor under ultrasound or CT guidance or under direct vision. Each target lesion receives about 30% (25-35%) of its volume per session (about 10% at high-risk locations). The total volume per session is limited to 50 mL and may be increased to 100 mL after review by an independent Data Safety Monitoring Board. The first 6 participants form a safety lead-in, in which plasma chlorite, chlorate and chloride are measured. Efficacy is assessed on contrast-enhanced CT 7 to 28 days after the last session and during follow-up.
- Conditions
- Solid Tumor, Neoplasms
- Being tested
- Chlorine Dioxide Injection 2%
- Keywords
- chlorine dioxide, intratumoral injection, chemical ablation, local ablation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorine Dioxide Injection 2%Drug
Ready-to-use 2% (w/w) chlorine dioxide in 0.9% sodium chloride, injected directly into the tumor under ultrasound or CT guidance or under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral Chlorine Dioxide Injection 2% | Experimental | Image-guided or direct-vision intratumoral injection of about 30% (25-35%) of lesion volume per lesion (about 10% at high-risk locations); total volume per session up to 50 mL, increased to 100 mL after DSMB review; up to 4 sessions per lesion, about 7 days apart, within 60 days. Receives: Drug: Chlorine Dioxide Injection 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities
Dose-limiting toxicities as defined in the protocol (Section 8), assessed after each treatment session.
Measured: 28 days after each treatment session
Number of participants with treatment-emergent adverse events
Any adverse event graded by CTCAE v5.0, from the first treatment session onward.
Measured: From first treatment session up to 12 months
Number of participants with grade 3 or higher adverse events
Adverse events of CTCAE v5.0 grade 3 or higher.
Measured: From first treatment session up to 12 months
Number of participants with serious adverse events
Serious adverse events as defined in 21 CFR 312.32.
Measured: From first treatment session up to 12 months
Number of participants with adverse events related to study drug
Adverse events assessed by the investigator as possibly, probably or definitely related to Chlorine Dioxide Injection 2%.
Measured: From first treatment session up to 12 months
Percentage of deliveries with solution outside the lesion boundary
Number of deliveries in which intraprocedural imaging shows delivered solution outside the target lesion boundary, divided by the total number of deliveries, expressed as a percentage.
Measured: During each treatment session
Percentage of deliveries terminated by a mandatory stopping rule
Number of deliveries terminated by a stopping rule defined in the protocol (Section 7.6), divided by the total number of deliveries, expressed as a percentage.
Measured: During each treatment session
Number of participants with non-target tissue injury
Injury to tissue outside the treatment zone attributable to delivered solution, assessed clinically and on imaging.
Measured: During each treatment session and up to 28 days after
Secondary outcomes (17)
Lesion-level complete non-viable radiological response rate
Percentage of target lesions with no residual viable tumor on contrast-enhanced imaging.
Measured: 7 to 28 days after the last treatment session
Patient-level complete non-viable radiological response rate
Percentage of participants with complete non-viable response of all lesions, among participants in whom all visible lesions were injected.
Measured: 7 to 28 days after the last treatment session
Necrosis percentage per target lesion
Necrosis proportion = 1 - (residual viable volume / baseline lesion volume), expressed as a percentage, per target lesion.
Measured: 7 to 28 days after the last treatment session
Number of target lesions by necrosis grade
Target lesions categorized by necrosis grade: complete; 90% or more; 50% to less than 90%; less than 50%.
Measured: 7 to 28 days after the last treatment session
Maintenance of complete non-viable response
Percentage of target lesions with complete non-viable response that remain without residual viable tumor on imaging.
Measured: 3, 6 and 12 months after the first treatment session
Objective response by RECIST 1.1
Percentage of participants with complete or partial response of target lesions according to RECIST 1.1.
Measured: Up to 12 months
Pain score on the numeric rating scale
Patient-reported pain on an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable).
Measured: Before and 24 hours, 7 days and 28 days after each treatment session
Number of participants with cessation of tumor bleeding
Among participants with a bleeding target lesion at baseline, the number in whom bleeding stopped.
Measured: 24 hours, 7 days and 28 days after each treatment session
Maximum plasma chlorite concentration
Maximum observed plasma chlorite concentration measured by validated ion chromatography in safety lead-in participants. Values below the limit of quantification are reported as such.
Measured: Before and up to 24 hours after the first treatment session
Maximum plasma chlorate concentration
Maximum observed plasma chlorate concentration measured by validated ion chromatography in safety lead-in participants. Values below the limit of quantification are reported as such.
Measured: Before and up to 24 hours after the first treatment session
Change in plasma chloride concentration
Change from pre-treatment in plasma chloride concentration (mmol/L) in safety lead-in participants, interpreted against the physiological background.
Measured: Before and up to 24 hours after the first treatment session
Maximum methemoglobin level
Maximum blood methemoglobin level (% of total hemoglobin) measured by co-oximetry.
Measured: Before and up to 24 hours after each treatment session
Change in plasma free hemoglobin
Change from pre-treatment in plasma free hemoglobin (mg/dL).
Measured: Before and up to 24 hours after each treatment session
Change in serum haptoglobin
Change from pre-treatment in serum haptoglobin (mg/dL).
Measured: Before and up to 24 hours after each treatment session
Change in serum lactate dehydrogenase
Change from pre-treatment in serum lactate dehydrogenase (U/L).
Measured: Before and up to 24 hours after each treatment session
Change in total bilirubin
Change from pre-treatment in total bilirubin (mg/dL).
Measured: Before and up to 24 hours after each treatment session
Local control rate with retreatment permitted
Percentage of treated target lesions without viable tumor at the treated site, with retreatment of residual or recurrent tumor permitted as specified in the protocol. Retreatment is not counted as treatment failure.
Measured: 3, 6 and 12 months after the first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SunGlow Innovations LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing WanBincell Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xuewu Liu, Study director, SunGlow Innovations LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911293
- Sponsor's protocol ID
- CDX-101
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Arm Study of the Safety, Containment and Local Activity of Intratumoral Chlorine Dioxide Injection 2% in Patients With Advanced Extracranial Solid Tumors Accessible to Image-Guided Percutaneous or Direct Injection
- ClinicalTrials.gov ID
- NCT07911293
- Acronym / sponsor ID
- CDX-101
- Conditions
- Solid Tumor, Neoplasms
- Keywords
- chlorine dioxide, intratumoral injection, chemical ablation, local ablation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SunGlow Innovations LLCIndustry (pharma, biotech, devices)
- Collaborators
- Beijing WanBincell Biotechnology Co., Ltd.
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
The purpose of this study is to evaluate the safety of injecting a 2% chlorine dioxide solution directly into tumors in adults with advanced solid tumors, and to determine whether the injected solution stays within the tumor under real-time imaging guidance. Chlorine dioxide reacts with and destroys the tissue it contacts and is consumed locally within about a minute. Up to about 50 participants will receive up to 4 treatment sessions per lesion, about one week apart, and will be followed for 12 months.
Detailed description
Chlorine Dioxide Injection 2% is a ready-to-use solution of chlorine dioxide in 0.9% sodium chloride, injected into the tumor under ultrasound or CT guidance or under direct vision. Each target lesion receives about 30% (25-35%) of its volume per session (about 10% at high-risk locations). The total volume per session is limited to 50 mL and may be increased to 100 mL after review by an independent Data Safety Monitoring Board. The first 6 participants form a safety lead-in, in which plasma chlorite, chlorate and chloride are measured. Efficacy is assessed on contrast-enhanced CT 7 to 28 days after the last session and during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumoral Chlorine Dioxide Injection 2% | Experimental | Drug: Chlorine Dioxide Injection 2%Image-guided or direct-vision intratumoral injection of about 30% (25-35%) of lesion volume per lesion (about 10% at high-risk locations); total volume per session up to 50 mL, increased to 100 mL after DSMB review; up to 4 sessions per lesion, about 7 days apart, within 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >= 18 years.
- Histologically confirmed extracranial solid tumor (primary, locally recurrent or metastatic) that is advanced or unresectable (technically unresectable, medically inoperable, without a remaining standard curative surgical option, or with curative treatment at disproportionate cost such as loss of an entire organ or major function, as documented by a multidisciplinary team), or that has active disease after standard therapy and for which standard local treatment is assessed as unsuitable.
- At least 1 and no more than 10 target lesions at entry. A target lesion is a non-intracranial lesion, visible on imaging, that can be safely reached by ultrasound- or CT-guided percutaneous puncture or injected under direct vision. Not every visible lesion has to be injectable. Non-target lesions may be present and are recorded. Where safe and feasible, all safely reachable visible lesions are listed as target lesions.
- Contrast-enhanced CT (with ultrasound or MRI where needed) completed before entry, establishing the inventory of all visible lesions and of target lesions with their volumes. PET-CT is encouraged but not required.
- Every target lesion <= 10 cm in greatest dimension.
Key exclusion criteria (11 listed)
- No lesion that can be safely punctured or injected under direct vision, or the lesion(s) to be treated encase major vessels or nerves such that the risk of access is unacceptable.
- Severe coagulopathy or high bleeding risk.
- Uncontrolled serious infection, systemic decompensation, severe cachexia or multi-organ failure.
- Pregnancy or lactation.
- Psychiatric or cognitive impairment preventing cooperation.
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 |
|---|---|---|
| Chlorine Dioxide Injection 2%Ready-to-use 2% (w/w) chlorine dioxide in 0.9% sodium chloride, injected directly into the tumor under ultrasound or CT guidance or under direct vision. | Drug | Intratumoral Chlorine Dioxide Injection 2% |
Primary outcome
Number of participants with dose-limiting toxicities
Time frame: 28 days after each treatment session
Dose-limiting toxicities as defined in the protocol (Section 8), assessed after each treatment session.
Number of participants with treatment-emergent adverse events
Time frame: From first treatment session up to 12 months
Any adverse event graded by CTCAE v5.0, from the first treatment session onward.
Number of participants with grade 3 or higher adverse events
Time frame: From first treatment session up to 12 months
Adverse events of CTCAE v5.0 grade 3 or higher.
Number of participants with serious adverse events
Time frame: From first treatment session up to 12 months
Serious adverse events as defined in 21 CFR 312.32.
Number of participants with adverse events related to study drug
Time frame: From first treatment session up to 12 months
Adverse events assessed by the investigator as possibly, probably or definitely related to Chlorine Dioxide Injection 2%.
Percentage of deliveries with solution outside the lesion boundary
Time frame: During each treatment session
Number of deliveries in which intraprocedural imaging shows delivered solution outside the target lesion boundary, divided by the total number of deliveries, expressed as a percentage.
Percentage of deliveries terminated by a mandatory stopping rule
Time frame: During each treatment session
Number of deliveries terminated by a stopping rule defined in the protocol (Section 7.6), divided by the total number of deliveries, expressed as a percentage.
Number of participants with non-target tissue injury
Time frame: During each treatment session and up to 28 days after
Injury to tissue outside the treatment zone attributable to delivered solution, assessed clinically and on imaging.
17 secondary outcomes
Lesion-level complete non-viable radiological response rate
Time frame: 7 to 28 days after the last treatment session
Patient-level complete non-viable radiological response rate
Time frame: 7 to 28 days after the last treatment session
Necrosis percentage per target lesion
Time frame: 7 to 28 days after the last treatment session
Number of target lesions by necrosis grade
Time frame: 7 to 28 days after the last treatment session
Maintenance of complete non-viable response
Time frame: 3, 6 and 12 months after the first treatment session
Objective response by RECIST 1.1
Time frame: Up to 12 months
Pain score on the numeric rating scale
Time frame: Before and 24 hours, 7 days and 28 days after each treatment session
Number of participants with cessation of tumor bleeding
Time frame: 24 hours, 7 days and 28 days after each treatment session
Maximum plasma chlorite concentration
Time frame: Before and up to 24 hours after the first treatment session
Maximum plasma chlorate concentration
Time frame: Before and up to 24 hours after the first treatment session
Change in plasma chloride concentration
Time frame: Before and up to 24 hours after the first treatment session
Maximum methemoglobin level
Time frame: Before and up to 24 hours after each treatment session
Change in plasma free hemoglobin
Time frame: Before and up to 24 hours after each treatment session
Change in serum haptoglobin
Time frame: Before and up to 24 hours after each treatment session
Change in serum lactate dehydrogenase
Time frame: Before and up to 24 hours after each treatment session
Change in total bilirubin
Time frame: Before and up to 24 hours after each treatment session
Local control rate with retreatment permitted
Time frame: 3, 6 and 12 months after the first treatment session
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
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.
Xuewu Liu study director
SunGlow Innovations LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chlorine Dioxide Injection 2% in people with Solid Tumor and Neoplasms, run by SunGlow Innovations LLC.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Xuewu Liu (+86 186 0119 6898, xuewu.liu@cdsxcancer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities (time frame: 28 days after each treatment session). The study lists 8 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 2 Nov 2026.