Clinical trial · Interventional
Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Phase I Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
NCT07772882CI-TRIAL-00122758not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, Phase 1 clinical study to evaluate the safety, tolerability, PK profiles, and clinical activity of IV and PO arginine supplementation + SOC chemoimmunotherapy regimens in participants with PROC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Peritoneal Carcinoma | Fallopian Tube Neoplasm | PROBABILISTIC | 0.70 |
| Platinum Resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A3 Expansion | Drug | — | UNRESOLVED |
| B3 Expansion | Drug | — | UNRESOLVED |
| Cohort A1 | Drug | — | UNRESOLVED |
| Cohort A2 | Drug | — | UNRESOLVED |
| Cohort A3 | Drug | — | UNRESOLVED |
| Cohort B1 | Drug | — | UNRESOLVED |
| Cohort B2 | Drug | — | UNRESOLVED |
| Cohort B3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CPS>1, physician's choice for Cohort A or Cohort B
- description
- Cohort A: Cohort A1\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine Cohort A2\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine Cohort A3\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine A3 Expansion\_Continue previous regimen OR Cohort B: Cohort B1\_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine Cohort B2\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine Cohort B3\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine B3 Expansion\_ Continue previous regimen
- interventionNames
- Drug: Cohort A1
- Drug: Cohort A2
- Drug: Cohort A3
- Drug: A3 Expansion
- Drug: Cohort B1
- Drug: Cohort B2
- Drug: Cohort B3
- Drug: B3 Expansion
- type
- EXPERIMENTAL
- label
- CPS<1, must be assigned to Cohort B
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.