STC-1010 Immunotherapy for Colorectal Cancer
This study is testing a new immunotherapy called STC-1010 for people with colorectal cancer that has spread (metastatic) or is locally advanced and cannot be removed by surgery. STC-1010 will be given along with other immune-boosting medicines (cyclophosphamide and GM-CSF) and standard chemotherapy (mFOLFOX6, with or without bevacizumab). The first part of the study will look at the safety and best dose of STC-1010. The second part will measure how well the treatment prevents the cancer from growing for 12 months. You may be able to join if you are 18-75 years old and have this type of colorectal cancer. The study plans to enroll 90 participants.
- Study design
- This is a Phase I/IIA, first-in-human, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will enroll about 90 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment prevents cancer growth for 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
At a glance
Conditions
Where it's being run
9 sites across 3 statesWho to contact
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What this trial measures
- Phase 1: To determine overall safety profile, recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)28 days
Endpoint/Outcome Measures: Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
- Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS) rate12 months
Progression Free Survival (PFS) rate at 12 months from STC-1010 + IS regimen initiation, defined as the proportion of participants alive and without progression (i.e., participants with complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) at 12 months according to RECIST 1.1