Clinical trial · Interventional
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
NCT03189030CI-TRIAL-00047441terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to business realignment
Summary
Brief summary (as posted)
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pLADD | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- pLADD treatment cycle is once every 3 weeks; starting dose 1×10\^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10\^9 CFU
- interventionNames
- Biological: pLADD
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- Through study completion, an average of 12 months
- description
- Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) * able to provide adequate tumor tissue from at least 1 accessible tumor site * completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening * on maintenance standard-of-care chemotherapies or on treatment holiday * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * adequate organ function * progression of disease at the time of Enrollment Exclusion Criteria: * BRAF V600E mutation * known allergy to both penicillin and sulfa drugs * implanted devices that cannot be easily removed * immunodeficiency, immune compromised state or receiving immunosuppressive therapy
References
Publications (0)
Data not yet available
No reference posted for this study.