TAC T-cells for the Treatment of HER2-positive Solid Tumors (NCT04727151) | Clinical Trial Compass
TerminatedPhase 1/2
TAC T-cells for the Treatment of HER2-positive Solid Tumors
Stopped: Study terminated by Sponsor for commercial reasons
United States28 participantsStarted 2021-04-19
Plain-language summary
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor.
This is an open-label, multicenter Phase 1/2 study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Age ≥ 18 years at the time of informed consent.
✓. For Phase 1 and Phase 2:
✓. Histologically confirmed advanced, metastatic, unresectable solid tumors (regardless of PD-L1 expression levels; Phase 1 monotherapy) and histologically confirmed advanced, metastatic, unresectable gastric or esophageal adenocarcinoma (regardless of PD-L1 expression levels for Phase 1 combination therapy and Phase 2) after at least 2 prior lines of therapy (Phase 1) or after at least 2 and no more than 4 prior lines of therapy (Phase 2).
✓. HER2+ incurable malignancies for which no standard-of-care HER2 targeted therapy exists may be enrolled regardless of the number of prior treatment lines, as long as in the opinion of the investigator the subject would be unlikely to tolerate or derive clinically meaningful benefit from other available treatment options.
✓. For breast cancer subjects, both prior lines of therapy must have included HER2-targeted agents per current standard-of-care.
✓. Subjects with solid tumors with genetic alterations and mutations (such as BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies or refused such approved targeted therapy for their cancers prior to enrollment, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies.
What they're measuring
1
Phase 1: Incidence of Dose Limiting Toxicities (DLTs)
✓. Measurable disease per RECIST 1.1 at time of enrollment.
Exclusion criteria
✕. Intolerant to any component of TAC01-HER2.
✕. Prior treatment with any of the following:
✕. Adoptive cell transfer of any kind, including CAR T cells
✕. Gene therapy
✕. Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter.
✕. Receipt of a live or live-attenuated vaccine within 30 days prior to study treatment.
✕. Monoclonal antibody (mAb), including PD-1 and PD-L1, therapies within 21 days prior to leukapheresis.
✕. Radiation within 28 days prior to enrollment. Palliative radiation is allowed up to 14 days prior to enrollment if non-irradiated lesions are present.