Can inhaled manganese make ovarian cancer immunotherapy hit harder?

NCT ID NCT07822646

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether adding inhaled manganese chloride to standard chemotherapy and an anti-PD-1 immunotherapy can help people with advanced ovarian cancer that has worsened after at least two prior treatments. The trial enrolls about 120 participants and randomly assigns them to receive either the manganese combination or a placebo alongside the same chemotherapy and immunotherapy. The main goal is to see whether the manganese combination lengthens the time before the cancer grows or the person dies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inhaled manganese chloride added to chemotherapy and an anti-PD-1 immunotherapy
What this could lead to
If it works, adding manganese to standard chemotherapy and immunotherapy could become a new way to treat ovarian cancer that has come back after earlier treatment.
What could go wrong
This is a phase 3 trial, so the approach is still experimental. Manganese priming may not improve outcomes, and combining it with chemotherapy and immunotherapy could add side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with histologically or cytologically confirmed epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer. 2. Patients who have received at least two prior lines of systemic therapy, including at least one platinum-based regimen. 3. Patients who experienced disease progression during or within 6 months after completion of the most recent line of systemic therapy. Note: This most recent therapy is not required to be platinum-based and may be any systemic treatment (chemotherapy, targeted therapy, or other anticancer therapy). 4. Patients with at least one measurable lesion. 5. Patients who have received immunotherapy (anti-PD-1 antibodies, anti-PD-L1 antibodies), or bevacizumab, are not restricted from enrollment. 6. Expected survival of more than 6 months. 7. Age over 18 years. 8. Patient weight \> 40 kg. 9. ECOG performance status ≤ 2. 10. Peripheral blood white blood cell count \> 3.5×10 /L. 11. Bone marrow reserve and liver and kidney function (the following laboratory tests should be performed before initial treatment to prove): * Absolute neutrophil count (ANC) ≥ 1,000/mm ; * Hemoglobin \> 80 g/dL; * Platelet count \> 80,000/mm ; * ALT/AST \< 3×ULN; * Serum creatinine \< 3×ULN; * Total bilirubin level \< 3×ULN. 12. No significant hereditary diseases. 13. Normal liver and kidney biochemical indicators. 14. Completed the last systemic anticancer therapy at least 4 weeks prior to enrollment, with resolution of all treatment-related adverse events to grade ≤1 according to NCI-CTCAE v5.0, with the exception of alopecia and other clinically insignificant toxicities deemed acceptable by the investigator. 15. No treatment with paclitaxel (albumin-bound) plus platinum in the past 3 months. 16. Voluntary participation and signing of informed consent, compliance with the trial treatment plan and visit schedule, and cooperation in observing adverse events and efficacy. Exclusion Criteria: 1. Absolute neutrophil count (ANC) \< 1×10 /L or platelets \< 80×10 /L or hemoglobin \< 80 g/dL (according to the normal values of the clinical trial center). 2. Serum total bilirubin levels higher than 3 times the upper limit of the reference range. 3. ALT, AST, or ALP levels higher than 3 times the upper limit of the reference range when there are no liver metastases; ALT, AST, or ALP levels higher than 5 times the upper limit of the reference range when there are liver metastases. 4. Patients receiving known strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin or St. John's Wort) of CYP3A4, or strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8; patients receiving treatment with potent P-gp inhibitors or inducers, or patients who cannot stop treatment with these agents for 2 weeks before the start of the study. 5. Subjects' bowel obstruction or requirement for bowel obstruction-related interventions within 3 weeks prior to first study drug administration; subjects with incomplete bowel obstruction who have returned to normal within 1 month before the first dose of the experimental drug can be included in the study after discussion by the researchers. 6. Patients with severe or uncontrolled ascites, defined as either of the following: a) symptomatic ascites corresponding to CTCAE ≥ Grade 2; b) history of therapeutic paracentesis for ascites within 3 weeks prior to enrollment. 7. Organ failure: * Heart: Grade III or IV. * Liver: Grade C according to Child-Pugh B liver function classification. * Kidney: Renal failure and uremia. * Lung: Severe respiratory failure symptoms. * Brain: Consciousness disorders. 8. T-cell tumors such as T-cell lymphoma or T-cell leukemia. 9. Major surgery within 4 weeks before enrollment, or planned major surgery during the study (excluding diagnostic surgery). 10. HIV antibody positive, or other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation. 11. History of Parkinson's disease or epilepsy, or occurrence of diseases that can induce seizures within 12 months before the study (including a history of transient ischemic attack, stroke, traumatic brain injury with consciousness disorders). 12. CTCAE grade 2 infections that do not respond to treatment or active clinically serious infections with CTCAE \> Grade 2. 13. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. 14. Patients with a history of allergic reactions to study drug components or suspected allergies. 15. Chronic diseases requiring immunotherapy or hormone therapy. 16. Patients who have received any investigational drug treatment within 30 days before the first dose of the trial drug. 17. Subjects with symptoms of brain or leptomeningeal metastasis. 18. Subjects with a history of malignant tumors (non-study tumor) within 3 years before the first dose of the trial drug. 19. History of the following diseases: interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, abdominal infection, etc.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Epithelial ovarian cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Bio-therapeutic, First Medical Center, Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • Department of Gynecologic Oncology, Shanxi Province Cancer Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Department of Obstetrics and Gynecology, First Medical Center, Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • Department of Obstetrics and Gynecology, North China University of Science and Technology Affiliated Hospital

    NOT_YET_RECRUITING

    Tangshan, Hebei, 063000, China

  • Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100007, China

  • Peking University International Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 102206, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.