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NCT07128355 · ClinicalTrials.gov registry record · Early Phase 1
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT07128355: Recruiting Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT07128355 is a Early Phase 1 study that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07128355, a Early Phase 1 study, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
Primary Outcome
Dose limiting radiation-related toxicities will be assessed by CTCAE v6.0. A dose limiting toxicity (DLT) will be defined as any patient who can't complete all radiation therapy (RT) fractions within 2-3 weeks for pre-specified toxicity or lab values attributable to radiation therapy, or development of RT-related toxicities within 30 days of completion of RT. Participants will be evaluable for DLT once they start protocol therapy.
Interventions
- DRUG Balstilimab
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- DRUG Botensilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-05-12 |
| Est. Completion | 2027-09 |
| Phase | Early Phase 1 |
What NCT07128355 shows while recruiting
NCT07128355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Balstilimab is the first listed.
NCT07128355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07128355 about?
NCT07128355 is a clinical study titled "Botensilimab, Balstilimab, and SBRT in Colorectal Cancer". This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
What is the current status of trial NCT07128355?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2026-05-12. Estimated completion is 2027-09.
What interventions are being tested in trial NCT07128355?
The interventions under investigation include: Balstilimab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT07128355?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07128355's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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