QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers (NCT04050709) | Clinical Trial Compass
CompletedPhase 1
QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers
United States16 participantsStarted 2019-07-18
Plain-language summary
Phase 1 study to assess the safety, preliminary efficacy of PD-L1 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years old.
✓. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
✓. Have histologically confirmed unresectable, locally advanced or metastatic solid cancer regardless of tumor PD-L1 expression levels.
✓. Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy and prior treatment with a checkpoint inhibitor as per FDA indication for current standard-of-care therapy is allowed.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST Version 1.1.
✓. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen obtained following the conclusion of the most recent anticancer treatment and be willing to release the specimen for exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
✓. Must be willing to provide pre- and post-infusion blood samples for exploratory analyses.
Exclusion criteria
✕
What they're measuring
1
MTD or HTD and RP2D.
Timeframe: 1 year
2
Incidence of DLTs and treatment-emergent adverse events
✕. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment- related complications.