Can an amino acid boost the power of ovarian cancer treatment?
NCT ID NCT07772882
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 89 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Alabama at Birmingham Womens & Infants Center
Birmingham, Alabama, 35233, United States
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Other studies related to the condition(s) this trial covers.
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- Real-World check: can a targeted ovarian cancer drug deliver outside clinical trials?
- Targeted Antibody-Drug could shrink Hard-to-Treat ovarian cancers