CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors (NCT06254807) | Clinical Trial Compass
UnknownPhase 1
CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors
United States6 participantsStarted 2024-01-08
Plain-language summary
This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Tumor tissue that is HER2-positive, following most recent therapy, by IHC using standard local assay resulting in 3+, or 2+ with confirmation by ISH testing. IHC and ISH assays and interpretation must follow the most recent ASCO/CAP guidelines and be performed in an accredited laboratory. Other tumor types (non-breast, non gastroesophageal) will be tested according to the breast cancer ASCO/CAP guidelines.
✓. Histologically confirmed recurrent or metastatic solid HER2-positive tumor for which there are no available curative treatment options, AND after failure of the following systemic therapies used for the treatment of recurrent (unresectable) and/or metastatic disease:
✓. Any participant with HER2-positive breast or gastroesophageal cancers who has previously been treated with at least 2 FDA approved anti-HER2 therapies in the advanced/metastatic setting, including, but not limited to checkpoint inhibitors (i.e., PD-1/L1 inhibitors) and/or other targeted therapies for actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, KRAS);
✓. Other HER2-positive tumor types must have progressed following treatment with at least 2 prior standard of care lines of therapy, including, but not limited to checkpoint inhibitors (i.e., PD-1/L1 inhibitors) and/or other targeted therapies for actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, KRAS).
✓. Participant must be willing and able to undergo on-study tumor tissue biopsy procedures to provide samples for biomarker analysis pre- and post-CT-0525 infusion:
✓. A participant whose tumor is not amenable to perform a safe post-baseline biopsy for the post-baseline translational studies may be allowed on the trial by mutual agreement of the Principal Investigator and Sponsor;
✓. Archived tumor tissue biopsy taken after progression on the most recent therapy is acceptable to be used in lieu of a pre-treatment biopsy for translational studies.
What they're measuring
1
Assess the safety and tolerability of CT-0525 by estimating the frequency and severity of adverse events in participants with HER2 overexpressing solid tumors.
. At least one measurable lesion (that will not be biopsied for eligibility and/or translational protocol requirements) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator/site.
Exclusion criteria
✕. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study subjects of reproductive potential must have a negative urine pregnancy test at enrollment. The urine pregnancy test will need to be repeated prior to treatment if greater than 4 weeks has lapsed between the enrollment pregnancy test and treatment.
✕. Known and previously documented human immunodeficiency virus (HIV) infection. Screening HIV test is not required in the absence of history or clinical suspicion.
✕. Active hepatitis B or hepatitis C infection.
✕. Diagnosis of immunodeficiency or exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Nasal or oral inhalers are permissible.
✕. Physiologic replacement doses of steroids (mineralocorticoid or less than or equal to a prednisone 10 mg daily dose) are permissible.
✕. Any uncontrolled active medical disorder that would preclude participation as outlined.
✕. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.