TAC T-cells for Gastric Cancer
(TACTIC-2 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Triumvira Immunologics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with HER2-positive stomach or gastroesophageal cancer that has returned or didn't respond after at least two treatments can join. They should be fairly active (ECOG 0-1), have organs working well, and a life expectancy over 12 weeks. Breast cancer patients must have had HER2-targeted therapy before.

Inclusion Criteria

Measurable disease per RECIST Version 1.1.

Life expectancy of at least 12 weeks

I am 18 years old or older.

+13 more

Exclusion Criteria

I have a recent heart condition.

I have an active inflammatory, neurological disorder, autoimmune disease, or infection.

Participant Groups

The trial is testing TAC01-HER2, a new type of cell therapy where patient's own immune cells are modified to attack cancer, alone and combined with pembrolizumab. It aims to find the safest dose, how it affects the body, and if it works against these cancers.

2Treatment groups

Experimental Treatment

Group I: TAC01-HER2 plus pembrolizumabExperimental Treatment1 Intervention

Lymphodepletion followed by TAC01-HER2 as a single IV infusion, followed by pembrolizumab administration.

Group II: TAC01-HER2Experimental Treatment1 Intervention

Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration.