Clinical trial · Interventional
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)
A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy
NCT01966289CI-TRIAL-00050962completedPhase 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 study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CY | Drug | — | UNRESOLVED |
| GVAX | Biological | — | UNRESOLVED |
| SGI-110 | Drug | Guadecitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1:CY/GVAX concurrently with SGI-110
- description
- During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2, the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 Granulocyte macrophage-colony stimulating factor (GM-CSF) secreting cells, and SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
- interventionNames
- Drug: CY
- Biological: GVAX
- Drug: SGI-110
- type
- EXPERIMENTAL
- label
- Cohort 2: CY/GVAX after SGI-110
- description
- During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2, Cyclophosphamide (CY) is administered on Day 8 at 200 mg/m2, and the colon cancer tumor vaccine (GVAX) is administered on Day 9 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 3. Adequate organ function as defined by study-specified laboratory tests 4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug 5. Signed informed consent form 6. Willing and able to comply with study procedures Exclusion Criteria: 1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions 2. Systemically active steroid use 3. Another investigational product within 28 days prior to receiving study drug 4. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug 5. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug 6. Pregnant or lactating 7. Unwilling or unable to comply with study procedures
References
Publications (1)
- DERIVEDBever KM, Thomas DL 2nd, Zhang J, Diaz Rivera EA, Rosner GL, Zhu Q, Nauroth JM, Christmas B, Thompson ED, Anders RA, Judkins C, Liu M, Jaffee EM, Ahuja N, Zheng L, Azad NS. A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint. Clin Epigenetics. 2021 Feb 2;13(1):25. doi: 10.1186/s13148-021-01014-8. PMID 33531075