Clinical trial · Interventional
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)
A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer Patients Without Life-Prolonging Therapies of Demonstrated Clinical Benefit (PAYLOAD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sufficient patients enrolled to end study
Summary
Brief summary (as posted)
This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan. RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| RRx-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RRx-001 + Irinotecan
- description
- Cohorts of participants with an advanced, malignant, solid tumor(s) will receive weekly doses of RRx-001 for 3 weeks, switching at week 4 to every-other-week treatments of RRx-001 with irinotecan.
- interventionNames
- Drug: RRx-001
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Number, frequency and type of adverse events
- timeFrame
- 14 Weeks
Secondary outcomes (4)
- measure
- Duration of clinical benefit rate
- timeFrame
- 1 year
- description
- Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\] criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined. * Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening. * Measurable disease per RECIST v1.1 by radiographic techniques * Acceptable liver function, serum creatinine and hematological status * Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001. * Subjects with brain metastases are eligible Exclusion Criteria: * Concurrent anticancer therapy; however, radiotherapy is allowed * Any history of hypersensitivity to irinotecan * Cholangitis that required treatment or intervention within 4 weeks of study enrollment * Bilirubin \> 2.0 mg/dL * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * If female, subject is pregnant and/or breastfeeding. * UGT1A1\*28 homozygote or heterozygote * BMI \>35
References
Publications (0)
Data not yet available