A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Tumor, Solid
In brief
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.
Key facts
- Study ID
- NCT05108623
- Run by
- MiNK Therapeutics
- People needed
- 34
- Starts
- 2022-01-28
- Expected to finish
- 2024-01-02
- Last updated by the study team
- 2024-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed
- Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study
- No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the Principal Investigator
You may not qualify if…
- Concurrent invasive malignancy
- Brain and/or leptomeningeal metastases that are untreated or require current therapy
- Prior radiotherapy within 2 weeks of start of study treatment
Where it is running
- University of Southern California — Los Angeles, California, United States
- University of Colorado — Aurora, Colorado, United States
- Norton Cancer Health — Louisville, Kentucky, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- University of Cincinnati Cancer Center — Cincinnati, Ohio, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- LifeSpan - Rhode Island Hospital — Providence, Rhode Island, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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