Can an amino acid boost the power of ovarian cancer treatment?

NCT ID NCT07772882

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase 1 trial is testing whether adding arginine, a common amino acid, to standard chemotherapy and immunotherapy can help people with platinum-resistant ovarian, fallopian tube, or peritoneal cancer. The study includes about 24 adults whose cancer has stopped responding to platinum-based treatments. Participants receive arginine either as a daily oral supplement or as an intravenous infusion, alongside weekly paclitaxel and pembrolizumab, with or without bevacizumab. The main goal is to check the safety and tolerability of these combinations, while also looking at how well they might shrink tumors.

What this could mean

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

Active substance
Arginine (an amino acid supplement) given orally or intravenously, combined with standard chemotherapy (paclitaxel) and immunotherapy (pembrolizumab) with or without bevacizumab.
What this could lead to
If it works, adding arginine could make standard treatments more effective for a hard-to-treat ovarian cancer, potentially slowing tumor growth or shrinking tumors.
What could go wrong
This is an early, small phase 1 trial focused on safety, so it may not show clear benefit. Arginine supplements can cause digestive issues or other side effects, and the combination may not improve outcomes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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 89 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. Must be at least 18 years of age 2. ECOG performance status of 0 or 1 (see Appendix A). 3. Patient must be a candidate for either cohort A or cohort B treatment backbone. * For patients enrolling on treatment cohort A, PD-L1 positivity must be ≥1. Patient's with PD-L1 positivity ≥1% can enroll in cohort B at physician's discretion. * If PD-L1 positivity is unavailable or is \<1%, patients can only enroll on treatment cohort B. 4. Patients must have high-grade serous or endometrioid histology 5. Recovery to baseline or ≤ Grade 1 CTCAE v.5.0 from toxicities related to the prior therapy, unless after discussion with the medical monitor the AE(s) are deemed clinically non-significant and/or stable on supportive therapy 6. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent 7. Patients must have adequate hematologic, liver and kidney functions prior to lead-in chemotherapy defined as: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L (1,500/μL) 2. Platelet count ≥ 100 x 109 /L (100,000/μL) without platelet transfusion in the prior 10 days 3. Hemoglobin ≥ 9.0 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 6. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN) 7. Serum albumin ≥ 2 g/dL. Exclusion Criteria: 1. History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid. 2. Patient unwilling/unable to receive daily arginine treatment (IV or oral) 3. Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks 4. Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required. 5. Actively treated auto-immune disease. 6. Taking medications that interfere with the urea cycle such as valproate or xanthine oxidase inhibitors. 7. Current intercurrent illnesses including active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias. 8. Patients with history of Peptic Ulcer Disease 9. Contraindications to receive standard of care treatment backbone with either paclitaxel, bevacizumab, pembrolizumab, or cyclophosphamide.

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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

    1 site. 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

  • University of Alabama at Birmingham Womens & Infants Center

    Birmingham, Alabama, 35233, United States

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