Clinical trial · Interventional
Trial of PalloV-CC in Colon Cancer
A Phase Ib Trial of Neoadjuvant PalloV-CC (Particle-delivered, Allogeneic Tumor Cell Lysate Vaccine for Colon Cancer) in Colon Cancer
- 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 study is a phase Ib prospective, open label study evaluating the effect of vaccination on the immune microenvironment of cancers with results compared to banked tissue from historical controls. Prospectively vaccinated patients will also serve as their own controls by comparing the immune microenvironment of the tumor in pre-treatment biopsies to post-treatment surgical specimens. This is also a dose-escalation study with consecutive enrollment and advancement of cohorts in an overlapping fashion.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PalloV-CC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1x10^8 particles of PalloV-CC
- description
- Intradermal injection of PalloV-CC weekly x 4 weekly
- interventionNames
- Biological: PalloV-CC
- type
- EXPERIMENTAL
- label
- 2x10^8 particles of PalloV-CC
- description
- Intradermal injection of PalloV-CC weekly x 4 weekly
- interventionNames
- Biological: PalloV-CC
- type
- EXPERIMENTAL
- label
- 4x10^8 particles of PalloV-CC
- description
- Intradermal injection of PalloV-CC weekly x 4 weekly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage I-IV (resectable) colon cancer patients identified prior to their definitive surgery 2. Diagnosis definitively confirmed by endoscopic biopsy with tumor tissue slides available for analysis 3. Asymptomatic and capable of waiting 4 weeks prior to definitive surgery 4. ECOG 0-1 performance 5. Not involved in other clinical trials 6. Capable of giving informed consent Exclusion Criteria: 1. Symptoms of obstruction or GI bleeding that necessitate more urgent surgical intervention 2. Cancer not definitively confirmed on endoscopic biopsy (i.e., Only high-grade dysplasia or adenoma identified, even if malignancy is suspected) 3. Known immune deficiency disease or HIV, active HBV, or active HCV 4. Steroids or other immunosuppressants received within 6 weeks of enrollment 5. Any colon cancer directed treatment (chemotherapy or radiation) received or planned prior to surgical resection 6. A history of any hematologic malignancy or myeloproliferative disease within 5 years prior to enrollment 7. Leukopenia or neutropenia within two weeks of presentation 8. ECOG \>/= 2 9. Pregnancy (serum or urine HCG) or breast feeding 10. Tbili \>1.8, Cr \>2, Hgb \<10, platelet count \<50,000, WBC \<2,000
References
Publications (0)
Data not yet available