Clinical trial · Interventional
Safety and Efficacy Study Using Rexin-G for Sarcoma
Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma
- 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)
Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rexin-G | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 1
- description
- Dose Level 1 of escalating doses of Rexin-G i.v.
- interventionNames
- Genetic: Rexin-G
- type
- EXPERIMENTAL
- label
- 3
- description
- Dose Level 3 of escalating doses of Rexin-G i.v.
- interventionNames
- Genetic: Rexin-G
- type
- EXPERIMENTAL
- label
- 4
- description
- Dose Level 4 of escalating doses of Rexin-G i.v.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed recurrent or metastatic sarcoma that is measurable. 2. Adequate hepatic function: Total bilirubin \< 2.0 mg/dL (upper limit included); AST/ALT \< 2x institutional norm; alkaline phosphatase \< 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin \> 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits. 3. Performance status must be \< 1 (ECOG 0-1) with a life expectancy of at least 3 months. 4. Hemoglobin \> 9 gms% 5. Absolute granulocyte count \> 1000/uL, and platelet count \> 100,000/uL. 6. Serum creatinine of less than 1.5 mg%. 7. There must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit. 8. Accessibility of peripheral or central IV line 9. Age \> 10 years 10. Patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to Grade 1 or less toxicity. 11. The ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years. 2. Woman who are pregnant or nursing 3. Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception. 4. Patients who are transfusion dependent (more than one transfusion per month) 5. Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol. 6. Patient who do not meet the inclusion criteria.
References
Publications (0)
Data not yet available