Adults 18 to 99, any sex, with Colorectal Cancer or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)Primary· Date treatment consent signed to date off study, approximately 24 months and 8 days
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one o
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
6
DL2 - CTX, SBRTx3 Days, and AMP-224
9
Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 AnalysesSecondary· Baseline and post infusion AMP-224 (e.g. 15 minutes after infusion ended)
This outcome measure only represents the number of participants with metastatic colorectal cancer who had specimens collected for pre and post pharmacokinetic (PK) AMP-224 analyses.
Pre AMP-224
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
6
DL2 - CTX, SBRTx3 Days, and AMP-224
9
Post AMP-224
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
6
DL2 - CTX, SBRTx3 Days, and AMP-224
9
Overall Survival in Patients With Colorectal Cancer Following Treatment With AMP-224 in Combination With SBRTSecondary· Baseline to end of study, which is date of death. Average time participants were followed was 10.6 months.
Overall survival is defined as the time from treatment start date until date of death or date last known alive.
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
4.3
1.2 – 8.9
DL2 - CTX, SBRTx3 Days, and AMP-224
9.0
1.5 – 21.3
Count of Participants With Post-Treatment BiopsiesSecondary· Post treatment, day 29 +/- 7 days
Mandatory post treatment biopsies of the tumor were attempted on all patients.
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
6
DL2 - CTX, SBRTx3 Days, and AMP-224
0
Median Progression-free Survival in Patients With Colorectal CancerSecondary· Baseline to disease progression, an average of 2.6 months.
Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also con
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
1.7
0.9 – 3.3
DL2 - CTX, SBRTx3 Days, and AMP-224
2.7
0.3 – 12.8
Objective Response RateSecondary· Restaging was done every 8 weeks for an average of 2.6 months.
Objective response will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as Complete Response + Partial Response. Briefly, complete response (CR) is defined as the disappearance of all target lesions, and Partial Response is defined as "at least" 30% decrease in the sum of the diameters of the target lesions from baseline measurement.
Group
Value
95% CI
DL1 - CTX, SBRTx1 Day, & AMP-224
0
DL2 - CTX, SBRTx3 Days, and AMP-224
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 24 months and 8 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DL1 - CTX, SBRTx1 Day, & AMP-224
Serious: 4/6 (67%)
Deaths: 6/6
DL2 - CTX, SBRTx3 Days, and AMP-224
Serious: 2/9 (22%)
Deaths: 9/9
Serious adverse events (7 terms)
Reaction
System
DL1 - CTX, SBRTx1 Day, & A…
DL2 - CTX, SBRTx3 Days, an…
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Background:
\- T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in people with cancer. They think the drug might work even better when combined with a certain type of radiation therapy.
Objective:
\- To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic body radiation therapy (SBRT) directed to the liver.
Eligibility:
\- People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to the liver and not be responding to treatment.
Design:
* Participants will be screened with a medical history, physical exam, and blood and urine tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an electrocardiogram (ECG) heart test.
* Participants will have a small part of their tumor removed by needle (biopsy).
* Participants will have 8 study visits over about 10 weeks.
* At 1 visit, they will have another tumor biopsy.
* At 1 visit, they will get a chemotherapy drug through a vein (intravenous (IV)).
* At 6 visits, they will receive AMP-224 through an IV.
* At 1 or 3 visits, they will have SBRT. Computed tomography (CT) scans will map the position of their tumor. Radiation beams of different intensities at different angles will be directed to the tumor.
* At all visits, some screening procedures may be repeated.
* After treatment ends, participants will have 7 follow-up visits over about 5 months. Blood will be drawn. Some screening procedures may be repeated.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino
· Phase 3
· recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer
· Phase 1, PHASE2
· recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
· Phase 1, PHASE2
· recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes
· recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 22 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02298946.