TAC100-HER2

P1/2, N=30, Terminated, Triumvira Immunologics, Inc. | N=110 --> 30 | Trial completion date: Jun 2027 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Dec 2023; Study terminated by Sponsor for commercial reasons

P1/2, N=110, Active, not recruiting, Triumvira Immunologics, Inc. | Recruiting --> Active, not recruiting

This patient had progressed on 4 prior lines of therapy including trastuzumab and trastuzumab deruxtecan... Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6-8 x 106 cells/kg). Clinical trial information: NCT04727151.

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6–8 x 106 cells/kg).

P1/2, N=110, Recruiting, Triumvira Immunologics, Inc. | N=70 --> 110 | Trial completion date: Feb 2025 --> Jun 2027 | Trial primary completion date: Nov 2024 --> Jun 2025

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. Dose escalation is complete.

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan... Treatment with the novel T cell therapy, TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population, refractory to prior HER2 targeted treatments, including a complete reduction of target lesions in one patient. Dose escalation of TAC01-HER2 is ongoing.

Dose escalation of TAC01-HER2 is ongoing, with seven subjects treated and three more scheduled in Cohort 4. These results in a heavily pre-treated cancer population show manageable safety and promising clinical activity with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151.

In phase I dose escalation, the primary objective is to evaluate the safety of TAC01-HER2 at increasing doses of 0.3, 0.8, 3, and 8 x 106 cells/kg in HER2+ solid tumors (1+, 2+ or 3+ as identified by immunohistochemistry) in adult subjects who have progressed after ≥2 lines of systemic therapy. Dose limiting toxicities (DLTs) are assessed up to 28 days from cell infusion. In Phase II, dose expansion groups will further evaluate the safety, efficacy, and pharmacokinetics of the optimal TAC01-HER2 dose in HER2+ breast and other solid tumor types.

TAC01-HER2, a first-in-class, autologous TAC T cell product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors... The in vitro and in vivo data confirm strong and specific activity of HER2-targeted TAC γδ T cells against HER2-expressing tumor models and highlights the potential of the TAC platform in the development of an allogeneic product for therapeutic applications in solid tumors.

Dose escalation of TAC01-HER2 is ongoing, with the first subject being treated at DL 3. These results in a heavily pre-treated gastrointestinal cancer population show manageable safety and promising efficacy with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151.